LAS VEGAS, Oct. 14, 2026 /PRNewswire/ — The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced results from Late-Breaking Clinical Trial sessions at VIVA 2026, held at Bellagio Las Vegas.
For 24 years, VIVA (Vascular InterVentional Advances) has set the benchmark for premier education and clinical excellence in peripheral vascular disease. Known for delivering the most up-to-date, practice-changing data, VIVA brings together the latest science, technological innovation, and international expertise.
Comparison of a Sirolimus-Eluting Balloon vs Balloon Angioplasty for the Treatment of Femoropopliteal Artery Lesions
Presented by Jay Mathews, MD, MS
SELUTION4SFA is a prospective, multicenter, single-blinded, 2:1 randomized, controlled, clinical trial to evaluate superior efficacy and non-inferior safety of the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) compared to percutaneous transluminal angioplasty (PTA) in the treatment of patients with symptomatic peripheral artery disease (PAD) in the superficial femoral artery and proximal popliteal artery.
This study enrolled 300 subjects at 34 clinical sites in the United States (US), Europe (EU) and Asia. Subjects were randomized 2:1 to treatment with SELUTION SLR™ DEB or with commercially available PTA (POBA). The primary efficacy endpoint to test for superiority was primary patency of the target lesion at 12 months. The primary safety endpoint for non-inferiority was a composite of freedom from perioperative death at 30 days, and 12-month freedom from target limb amputation and CD-TLR. Other 12-month endpoints included Kaplan-Meier (KM) estimates of primary patency and freedom from CD-TLR.
Of the 300 patients enrolled, 205 were treated with SELUTION SLR™ DEB and 95 with PTA. Mean age was 70.8±9.4 years for DEB and 70.5 ± 9.1 years for POBA. 41.5% of DEB patients were diabetic compared to 40.0% of POBA patients (p=0.90). Lesion lengths in DEB and POBA were 9.3±5.8cm and 7.2±5.0cm (p=0.002), respectively. 50.5% of DEB lesions and 47.8% of POBA lesions were severely calcified (p=0.82).
SELUTION SLR™ DEB met superiority for efficacy compared to POBA (78.6% vs. 65.2%, p=0.019) and met non-inferiority for safety (92.8% vs. 84.2%, p<0.0001). Primary patency by KM estimate was 90.3% in DEB vs. 79.4% in POBA, and freedom from CD-TLR was 94.6% in DEB vs. 85.3% in POBA.
The SELUTION4SFA trial is the first investigational device exemption clinical trial and the first randomized clinical trial in the US for a sirolimus DEB compared to plain balloon angioplasty for the treatment of PAD.
Sirolimus-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease
Presented by Stefano Barco, MD, PhD
Peripheral artery disease involving the femoropopliteal segment commonly causes exertional symptoms, and restenosis after endovascular treatment frequently leads to repeat intervention. Although drug-coated balloons are used to improve durability, randomized evidence comparing sirolimus-coated versus standard uncoated balloons in this population has been limited.
This secondary analysis of the multicenter, randomized, blinded-endpoint SirPAD trial (ClinicalTrials.gov: NCT04238546) evaluated patients with femoropopliteal target lesions and no tissue loss. Patients had been randomized 1:1 to angioplasty with a sirolimus-coated balloon or a standard uncoated balloon. The main analysis included 597 patients; median age was 71 years, 34.7% were women, median target-lesion length was 150 mm, and 53.8% of lesions were total occlusions. Outcomes at 1 year included target-lesion revascularization (TLR), major adverse limb events, amputation or TLR, and all-cause mortality.
At 1 year, TLR occurred in 17.0% of patients treated with sirolimus-coated balloons versus 27.1% with uncoated balloons (absolute risk difference [ARD], –10.1%; 95% CI, –16.6 to –3.4; HR, 0.58; 95% CI, 0.40–0.82). Major adverse limb events occurred in 4.1% versus 8.9% (ARD, –4.8%; HR, 0.44; 95% CI, 0.22–0.88), and the composite of any unplanned amputation or TLR occurred in 17.7% versus 27.1% (ARD, –9.4%; HR, 0.60; 95% CI, 0.42–0.85). Target-limb revascularization occurred in 19.4% versus 28.4% (HR, 0.63; 95% CI, 0.45–0.89). Clinical improvement by at least one Rutherford category occurred in 76.2% versus 70.0% (RR, 1.09; 95% CI, 0.99–1.20). All-cause mortality was similar (3.7% vs. 5.3%; HR, 0.70; 95% CI, 0.32–1.51). Findings were consistent in the more restrictive lower-disease-burden subgroup.
These results suggest that sirolimus-coated balloon angioplasty reduces repeat revascularization and improves clinical outcomes compared with uncoated balloon angioplasty in patients with femoropopliteal artery disease without tissue loss.
24-Month Data From the SUCCESS PTA Study: Performance of a Novel Sirolimus-Eluting Balloon in Real-World Peripheral Artery Disease Patients
Presented by Thomas Zeller, MD
The objective of the SUCCESS PTA study is to evaluate the safety and efficacy of the novel SELUTION SLR™ 018 sirolimus-eluting balloon in the treatment of real-world patients with peripheral arterial disease (PAD). This is a report of the entire cohort at 24-month follow-up.
SUCCESS PTA is a real-world, prospective, multi-center, single-arm post-market study of the SELUTION SLR™ for treatment of de novo/restenotic lesions in SFA, popliteal, tibial and pedal arteries. 720 patients were enrolled at 27 sites in Europe, Asia, and South America from February 2021 to October 2023. The primary endpoint of the study is freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Major secondary endpoints are severe limb ischemia leading to an intervention or major vascular amputation and death. Follow-ups after 12 months are planned yearly for up to 5 years.
Baseline demographics included 468 males (65%), and the mean age was 70.7 years. Significant co-morbidities included diabetes mellitus (273; 37.9%), renal insufficiency (121; 16.8%) and 186 (25.8%) were CLTI patients (Rutherford 4, 5, or 6). The mean lesion length was 128.4 mm and the reference vessel diameter was 5.2 mm. 42.1% of the lesions were totally occluded and 36.3% had calcification grade 3 and 4. 24-month outcomes showed clinical improvement associated with 86.1% freedom from CD-TLR overall and 83.0% for the CLTI subgroup.
SUCCESS PTA is one of the largest studies of a sirolimus drug-eluting balloon (DEB), enrolling more than 700 real-world patients treated for PAD. The 24-month follow-up data highlight consistency and durability of SELUTION SLR™ DEB’s safety and efficacy in treating real-world PAD patients. The findings of this analysis will contribute valuable evidence toward the expanding role of sirolimus-based DEBs in the endovascular management of peripheral arterial disease.
Montelukast Reduces Risk of Major Adverse Limb Events After Endovascular Treatment: First Results of the CADET-PAD study
Presented by Mikołaj Maga, MD, PhD
Peripheral arterial disease (PAD) treatment includes risk factor reduction, optimal pharmacological treatment, walking training, and open-surgical or endovascular revascularization. Despite new techniques and the constant development of endovascular tools, restenosis, leading to artery occlusion, remains a frequent issue. Given the observed correlation between increased leukotriene synthesis and unfavorable endovascular treatment outcomes, the aim of this study was to assess the impact of leukotriene antagonist (montelukast) use on the rate of major adverse limb events (MALE).
In this prospective, double-blinded clinical trial, patients with PAD (Rutherford 3 and 4) undergoing endovascular treatment were enrolled. They were randomized 1:1 to two groups: a study group receiving 10 mg of montelukast daily for 12 months and a control group receiving a placebo. Both groups were additionally provided with standard optimal post-angioplasty pharmacological treatment. The follow-up visits, including physical examination, quality of life assessment, Doppler ultrasound, ABI/TBI, urine and blood sampling, were performed at 1, 3, 6, 9 and 12 months after revascularization.
200 patients (mean age 64.7 years, 78.9% Rutherford 3, 35.5% CAD, 39.0% DM t II, 88.0% hypertension) were enrolled. In the 12-month observation, there was a significant reduction of MALE in the montelukast group (n=16 vs n=34, p < 0.001). The primary patency rate after 12 months was higher in the montelukast group (84.0% vs 66.0%, p< 0.001), accompanied by greater improvements in quality of life (VascuQol, p< 0.01) and endothelial parameters (FMD, SI, p< 0.05). The 12-month MACE rate (n=2 vs n=6, p < 0.001), including death rate (n=1 vs n=3, p < 0.01), was significantly lower in the montelukast group.
Montelukast has been proven to be clinically effective in reducing the rate of MACE, including restenosis or reocclusion, in patients undergoing EVT. The results suggest that inhibition of the leukotriene-mediated inflammatory pathway may play a significant role in the treatment of atherosclerosis and should be considered, especially in patients with recurrent restenosis of unknown cause after revascularization.
Real-World 6-Month Outcomes of the Esprit BTK Drug-Eluting Resorbable Scaffold in CLTI: Results From the Post-Approval Study
Presented by Brian DeRubertis, MD
The Esprit BTK Post-Approval Study (PAS) evaluates the real-world safety and effectiveness of the Esprit™ BTK drug-eluting resorbable scaffold (DRS) in patients with infrapopliteal disease and chronic limb-threatening ischemia (CLTI). The Esprit BTK DRS combines temporary vessel scaffolding with local delivery of everolimus and resorbs over time, leaving no permanent implant. While the LIFE-BTK randomized trial demonstrated superior effectiveness compared with angioplasty, real-world evidence in broader and more clinically complex populations has been limited.
Esprit BTK PAS is a prospective, single-arm, multicenter, observational post-approval study conducted across 50 sites globally. The primary effectiveness endpoint is freedom from clinically driven target lesion revascularization (CD-TLR), while the primary safety endpoint is the composite of major adverse limb events (MALE) and perioperative death (POD).
Enrollment was completed at 210 patients; this analysis reports 6-month outcomes for the first 200 enrolled subjects. The cohort represented a highly complex CLTI population, with 64% presenting with an index wound, 63% classified as Rutherford-Becker class 5 or 6, 77% having diabetes, and 13% having end-stage renal disease (ESRD). Lesions were similarly challenging, with a mean length of 69 mm, 59% exhibiting moderate-to-severe calcification, 23% classified as TASC D, and 43% presenting as total occlusions.
At 6 months, freedom from CD-TLR was 93.8%, while the MALE + POD rate was 5.5%. MALE occurred in 3.9% of patients, POD in 1.7%, and no major reinterventions were reported. Amputation-free survival was 88%, and complete wound healing was observed in 52.9% of evaluable patients. Mortality and major amputations were concentrated among patients with advanced disease, particularly those with ESRD. Despite substantial clinical and lesion complexity, the Esprit BTK DRS demonstrated favorable 6-month safety and effectiveness outcomes, supporting its use in routine clinical practice and providing the first large-scale real-world evidence for a resorbable scaffold platform in patients with CLTI.
Clinical Outcomes of the MOTIV Sirolimus-Eluting Resorbable Scaffold in Rutherford Category 4 Versus Rutherford Category 5 Chronic Limb-Threatening Ischemia: Subgroup Analysis From the MOTIV Pivotal Trial
Presented by Ehrin Armstrong, MD
The MOTIV BTK Trial is a prospective, multicenter, single-blind, randomized controlled study designed to assess the safety and efficacy of the MOTIV sirolimus-eluting resorbable scaffold for treating de novo infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Because outcomes are known to differ by clinical severity, subgroup analyses were conducted in Rutherford Category (RC) 4 patients (ischemic rest pain) and RC5 patients (distal tissue loss), a higher-risk group with historically greater rates of endovascular failure.
A total of 292 patients were enrolled and randomized 1:1 to treatment with the MOTIV scaffold or standard percutaneous transluminal angioplasty (PTA). Of these, 202 patients (69.2%) were RC5 and 90 (30.8%) were RC4. Clinical and imaging follow-up was performed through 12 months. The primary efficacy endpoint was freedom from a composite of above-ankle amputation, target lesion occlusion, clinically driven target lesion revascularization, and binary restenosis.
The presentation will compare baseline lesion characteristics and key safety and efficacy outcomes between RC4 and RC5 subgroups. Despite the more advanced disease burden in RC5 patients, the MOTIV sirolimus-eluting resorbable scaffold showed consistent effectiveness and a favorable safety profile across both severity groups. Overall, the findings suggest scaffold-based sirolimus delivery may provide clinical benefit across the spectrum of CLTI, including patients presenting with advanced tissue loss, supporting the use of the MOTIV scaffold in high-risk infrapopliteal interventions.
Predictors of Major Bleeding in Acute Intermediate-Risk Pulmonary Embolism: Analysis From the HI-PEITHO Randomized Study
Presented by Michael N. Young, MD
The randomized HI-PEITHO study demonstrated that patients with acute intermediate-risk pulmonary embolism (PE) had reduced risk of defined clinical outcomes when treated with ultrasound-facilitated catheter-directed thrombolysis (USCDT) using the EKOS Endovascular System plus anticoagulation (AC) versus standard-of-care AC alone, with no excess major bleeding risk. The impact of potential predictors on major bleeding in the entire study cohort was assessed in post hoc analyses. Major bleeding assessment was based on International Society on Thrombosis and Haemostasis (ISTH) criteria as determined by a blinded Clinical Events Committee and occurring within 30 (+7) days of randomization in the intention-to-treat cohort. The overall major bleeding rate was low, and there was no significant difference between study groups (4.0% USCDT vs 3.0% AC; 2-sided P=0.64). No intracranial hemorrhage occurred in either group. Univariable and multivariable logistic regression were used to assess predictors of major bleeding. Four variables had significant (P<0.05) main or interaction effects in multivariable analysis: cancer, RV/LV ratio, baseline National Early Warning Score (NEWS), and sex. Of these, NEWS <7 was associated with reduced major bleeding risk for patients treated with USCDT, whereas cancer and RV/LV ≥1.5 were associated with increased risk for patients treated with anticoagulation alone. The other 20 variables that were assessed did not independently affect major bleeding. Multivariable analysis suggests that baseline factors differentially impact bleeding risk for patients treated with USCDT or anticoagulation alone.
Functional Recovery After Acute Intermediate-High Risk Pulmonary Embolism: Relationship Between 6-Minute Walk Distance and Wearable-Derived Step-Based Activity in the STORM-PE RCT
Presented by Robert Lookstein, MD, MHCDL
The STORM-PE RCT is the first RCT to include a consumer wearable cohort enabling evaluation of real-world, step-based actigraphy measures and correlation with clinic-based functional capacity (6MWD) during functional recovery after acute intermediate-high risk PE. Patients randomized to treatment with computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation or anticoagulation alone were screened for eligibility and consented for the wearable cohort; enrolled patients were asked to wear a Garmin VenuSq® smartwatch through the 90-day follow-up visit. Wearable data were transmitted from the watch to a digital health platform. Wearable-derived outcomes included daily total step count, walking bout characteristics (length, number, and duration), and daily peak 10-minute step count recorded within two prespecified epochs (days 8-28 and 8-91). High compliance was defined as wear time ≥10 hours per day for ≥9 compliant days (≥3 days per week) within these epochs. A correlation analysis was performed with measured 6MWD performed at 30- and 90-day follow-up visits.
Among 100 randomized patients, 65 enrolled in the wearable cohort (CAVT=33, AC=32). All actigraphy measures were positively correlated with 30-day 6MWD in both the full wearable and high-compliance cohorts during 8-28d. Notable correlations observed in the high compliance cohort (N=33) included median daily step count (r=0.44, P=0.010), walking bout length (r=0.57, P<0.001), bout number (r=0.41, P=0.018), bout duration (r=0.42, P=0.014) and daily peak 10-minute step count (r=0.47, P=0.006). Associations between 90-day 6MWD and step-based actigraphy measures were attenuated.
Novel consumer wearable PE evidence from STORM-PE is the first to show significant correlations between consumer wearable-derived, step-based actigraphy measures and 6MWD. Correlations with 6MWD were strongest with temporally matched wearable and clinically assessed data at 30 days, with attenuation by 90 days. These findings may support feasibility and clinical utility of integrating consumer wearable monitoring into post-PE recovery studies as a complementary measure of functional recovery alongside clinically assessed exercise capacity.
Safety and Effectiveness of the Laguna Thrombectomy System™ for Treatment of Pulmonary Embolism: Outcomes From the TRUST Pivotal Study
Presented by Jay Mathews, MD, MS
Purpose: Pulmonary embolism (PE) is a major cause of morbidity and early mortality, with RV failure driving clinical deterioration. Mechanical thrombectomy offers rapid hemodynamic improvement and reduction in right heart strain without thrombolytic-associated bleeding risks. The Laguna Thrombectomy System™, an intermediate and large-bore platform consisting of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System, was studied through a prospective, single-arm, multicenter, pivotal, IDE study called TRUST to evaluate its safety and effectiveness for the treatment of acute intermediate-risk PE.
Materials and Methods: Subjects with an RV/LV ratio > 0.9 on CTA, systolic blood pressure > 90 mmHg, heart rate ≤ 120 bpm, CTA evidence of proximal PE, and with PE symptom duration ≤ 14 days were eligible for enrollment. The primary safety endpoint was a composite of major adverse events (MAE) within 48 hours post-procedure. The primary effectiveness endpoint was a reduction in RV/LV ratio assessed by CTA at 48 hours post-procedure compared to baseline. Study oversight included an imaging core laboratory and a clinical events committee.
Results: All 107 subjects underwent successful thrombectomy using study devices. The MAE rate was 0.9% (1/107), driven by a single bleeding event; no device‑related deaths, pulmonary vascular injuries, cardiac injuries, or cardio‑respiratory deterioration occurred. The single bleeding event was not related to the investigational device. Mean RV/LV ratio improved from 1.66 to 1.12 at 48 hours (mean reduction 0.53, 95% CI 0.447–0.622), representing a 32% relative improvement. Mean duration of thrombectomy was 38 minutes.
Conclusions: TRUST demonstrates that the Laguna Thrombectomy System delivers rapid RV strain reversal, significant pulmonary hemodynamic improvement, and meaningful symptom reduction with a very low rate of major adverse events. These results support its role as a high‑performing, safe, and effective non‑thrombolytic mechanical thrombectomy treatment option for intermediate‑risk PE.
Results From Pulsatile Intravascular Lithotripsy to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease (POWER PAD II)
Presented by Jon C. George, MD, MBA
The POWER PAD II study was a prospective, single-arm, multicenter IDE clinical study to demonstrate the safety and effectiveness of the Pulse IVL system for treatment of calcified femoral and popliteal arteries in PAD subjects. The Pulse IVL system propagates hydraulic pressure waves through a noncompliant balloon to modify surrounding calcium.
A total of 115 subjects across 17 US sites were enrolled and treated with the Pulse IVL system. The mean age was 72 years and 65% of subjects were male. Almost 75% of the subjects were Rutherford class (RC) 3 and the majority had a history of hypertension and dyslipidemia. All lesions met the PARC definition of severe calcium, with an average lesion length of 86 mm and 82% stenosis. Most of the lesions were in the superficial femoral artery (72%) with both concentric and eccentric calcium present in 70% of the lesions.
The study met both its primary safety and effectiveness endpoints. For effectiveness, 98.3% of the subjects had a final residual diameter stenosis of <50%. For safety, 98.3% of subjects were free from new onset Major Adverse Events (MAE) within 30 days post-procedure. There were no serious adverse events related to the device. The study also demonstrated sustained results up to six months of follow-up. Patency was 94% and 91% at 30 days and 6 months, while the percentage of subjects with RC improvement was 88% and 93% at 30 days and 6 months, respectively. Ankle-brachial index increased from 0.76 at baseline to 0.99 at both 30 days and 6 months. No subjects required clinically driven target lesion revascularization.
The POWER PAD II study results demonstrate that the Pulse IVL system can be used for the treatment of calcific femoropopliteal disease.
Calcified Below-the-Knee Lesions Treated With the Shockwave Medical Peripheral Intravascular Lithotripsy System: Two-Year Outcomes From the DISRUPT PAD BTK II Study
Venita Chandra, MD
Background: Moderate-to-severely calcified infrapopliteal lesions remain among the most challenging lesions to treat and are increasingly encountered in patients with peripheral artery disease. Intravascular lithotripsy (IVL) for the treatment of patients with calcified below-the-knee (BTK) lesions has demonstrated excellent procedural success, low residual stenosis, and favorable one-year outcomes. This analysis reports two-year outcomes from the DISRUPT PAD BTK II study.
Materials and Methods: The prospective, multicenter, single-arm DISRUPT PAD BTK II study enrolled 250 subjects, of which 200 patients were Rutherford category (RC) 4 or 5 and 50 were RC3. Two-year endpoints included Kaplan-Meier (KM) estimates of freedom from clinically driven target lesion revascularization (CD-TLR) and major target-limb amputation. Major adverse limb events (MALE), change in RC, and VascuQoL scores were also assessed.
Results: 243 of the 250 patients received IVL therapy and there were 46 deaths, 30 withdrawals from the study, and 14 subjects lost to follow-up through 2 years. The two-year KM estimates of freedom from CD-TLR excluding amputation and major amputation for the full cohort were 81% and 94.8%, respectively. For the full cohort, the two-year rates of MALE, all-cause death, and above-the-ankle amputation were 29.1% (58/199), 23.8% (46/193), and 7.7% (12/155), respectively. Among eligible patients with follow-up, 76.6% were asymptomatic (RC0) or reported only mild claudication (RC1) at 2 years, and 85.2% had improved by at least one RC category. The mean improvement in total VascuQoL score at 2 years among evaluable patients was 5.8 ± 5.5 (p<0.001).
Conclusions: In the DISRUPT PAD BTK II study, patients with heavily calcified below-the-knee disease treated with IVL had low rates of repeat revascularization and major amputation, and had significant improvement in quality of life. These results support the long-term safety and effectiveness of IVL in the treatment of challenging patients with complex calcified BTK lesions.
Adjunctive Transdermal Continuous Oxygen Therapy Accelerates Surgical Wound Healing After Lower Extremity Revascularization: A Randomized Clinical Trial
Presented by Khanjan Nagarsheth, MD, MBA
Surgical site complications following lower extremity revascularization remain common and can contribute to prolonged recovery, graft complications, and limb loss. Transdermal continuous oxygen therapy (TCOT) delivers concentrated oxygen directly to the wound environment; however, its effectiveness in accelerating healing of postoperative vascular surgical incisions has not previously been evaluated in a randomized clinical trial.
This prospective, single-center randomized trial evaluated 118 adults undergoing elective lower extremity revascularization for atherosclerotic peripheral arterial disease. Following skin closure, patients were randomized 1:1 to TCOT using the EPIFLO device (3.0 mL/hour of 98%–100% oxygen for 28 days) plus standard wound care or standard wound care alone. Incision healing was assessed through 28 days using the modified Bates-Jensen Wound Assessment Tool, with follow-up through 90 days. The primary endpoint was the trajectory of incision healing over four weeks; surgical site infection was a secondary endpoint.
TCOT significantly accelerated wound healing compared with standard care (treatment effect 0.0060; 95% CI, 0.0014–0.0107; P=0.01). Complete healing at four weeks occurred in 69% of TCOT-treated patients versus 50% of controls (P=0.01), representing a 19-percentage-point absolute improvement. Median time to complete healing was reduced from 40 days with standard care to 25 days with TCOT. Surgical site infections occurred in three control patients and no TCOT patients (P=0.09), and no device-related adverse events were observed.
These findings demonstrate that adjunctive TCOT can significantly accelerate surgical incision healing following lower extremity revascularization. Larger multicenter studies are warranted to confirm these findings and define its role in postoperative vascular surgical care.
1-Year Outcomes From the PROMISE III Trial of Transcatheter Arterialization of the Deep Veins
Presented by Daniel G. Clair, MD
A subset of patients with chronic limb-threatening ischemia (CLTI) are not eligible for conventional endovascular or surgical revascularization treatment options and face poor outcomes, including high rates of mortality and major amputation. Transcatheter arterialization of the deep veins (TADV) with the purpose-built LimFlow System has demonstrated positive outcomes in the prior PROMISE trials. We report here the 1-year outcomes from the PROMISE III trial.
The PROMISE III trial is a prospective, multicenter, single-arm study. All enrolled patients had Rutherford class 5/6 disease and were independently confirmed as ineligible for endovascular or surgical interventions. Key exclusion criteria included systemic infection, rapidly deteriorating wounds, or advanced heart failure. Study conduct included an independent clinical events committee to adjudicate safety outcomes and a core laboratory to assess all wound images. Outcomes assessed through 1 year included Kaplan-Meier (KM) rates of limb salvage, survival, and amputation-free survival (AFS), as well as pain (0-10 score), wound healing status, and Rutherford classification.
A total of 100 patients (103 limbs) underwent TADV. All included limbs had non-healing ulcers or gangrene with 74.8% Rutherford class 5 and 25.2% class 6. Preexisting comorbidities included 80.0% with diabetes, 95.0% with hypertension, 63.0% with hyperlipidemia, 46.0% with chronic kidney disease, and 13.0% on dialysis.
At 1 year, the KM limb salvage rate was 84.1%, survival was 91.4%, and AFS was 76.3%. Pain decreased from a median of 6 at baseline to a median of 0 at 1 year. Wounds were completely healed or healing in 91.5% of treated limbs at 1 year. 64.1% of patients were in Rutherford class 4 or below with 45.3% in Rutherford class 0 (asymptomatic).
The 1-year outcomes from the PROMISE III trial build upon the favorable outcomes of the prior PROMISE studies and support the use of TADV in the treatment of no-option CLTI patients.
12-Month Outcomes for Patients with Complex PAD Conditions (Diabetes Mellitus, CTO, Long Lesions, and/or Calcified Lesions) Treated With DES From the ELEGANCE Registry
Presented by Eric A. Secemsky, MD, MSc
Purpose: The ELEGANCE registry prospectively evaluates endovascular PAD treatment using Ranger drug-coated balloon (DCB) or Eluvia drug-eluting stent (DES) with a focus on historically underrepresented populations to generate real-world evidence. The purpose of this analysis is to examine 12-month outcomes for ELEGANCE patients treated with DES by complex patient groups that are at higher risk for complications or restenosis.
Design: ELEGANCE registry patients who were treated with DES for femoropopliteal lesions and had completed the 12-month follow-up window were included. Complex patient subgroups were defined as: current diabetes mellitus (DM), chronic total occlusions (CTO), long lesions (LL) ≥150 mm, or lesions with moderate/severe calcification (Ca+). Kaplan-Meier analysis was used to estimate site-reported primary patency, freedom from CD-TLR, and freedom from major (above-ankle) amputation at 12 months.
Results: Among 382 DES-treated patients with 405 lesions, complex disease was common: 55.7% had current and medically-treated DM (N=195 patients), while 61.5% of lesions were CTOs (N=240 patients), 33.3% had LL ≥150 mm (N=135 patients), and 63.9% had moderate/severe Ca+ (N=241 patients). Overall, 36.2% of patients in this cohort had CLTI (Rutherford classification 4-6) at baseline. Clinical outcomes were favorable after 12 months, including primary patency of 93.2 ± 1.3%, freedom from CD-TLR of 94.1 ± 1.2%, and freedom from major amputation of 99.4 ± 0.4%. These findings were consistent across subgroups within DM, CTO, LL ≥150mm, and moderate/severe Ca+ subgroups, showing a range for primary patency of 93.6%–94.2%, freedom from CD-TLR of 94.2%–95.9%, and freedom from major amputation of 99.1%–99.6%.
Conclusion: Real-world patients from the ELEGANCE registry treated with DES for femoropopliteal lesions showed positive 12-month outcomes, including primary patency, freedom from CD-TLR, and freedom from major amputation. These outcomes remained consistent even when focusing on complex patient subgroups that historically have expectations of poorer outcomes and higher rates of restenosis.
9-Month Outcomes of the AGILITY Trial Iliac Cohort: A Prospective, Multicenter Study on Revello™, a Low-Profile Self-Expanding Covered Stent
Presented by Sean P. Lyden, MD
Background: AGILITY is a prospective, multicenter, single-arm IDE study to evaluate the safety and effectiveness of Revello™, a novel low-profile, self-expanding covered stent in patients with iliac artery lesions (NCT06111469).
Methods: The iliac cohort consisted of 120 iliac subjects across 28 international sites. The composite primary endpoint was defined as device and/or procedure-related death or myocardial infarction through 30 days, or clinically driven target lesion revascularization (CD-TLR), or target limb major amputation, or target lesion restenosis through 9 months and was evaluated against a performance goal (PG) of 19%. Secondary endpoints include technical and clinical success, freedom from CD-TLR, primary patency, and major adverse events (MAE).
Results: The iliac cohort had a mean age of 67.0 years, and 40.8% of the patients were female. The study included lesions with varied anatomical characteristics, TASC A (50.0%), TASC B (24.2%), TASC C (13.3%) and D (12.5%), occlusions (29.4%), involvement of the external iliac artery (51.7%), and moderate-to-severe calcification (49.6%). The primary binary composite endpoint was 3/108 (2.8%; 95% CI, 0.6%-7.9%; one-sided P<0.0001 versus PG 19%). Acute lesion-, procedural-, technical- and sustained clinical success rates were 100.0%, 97.5%, 99.3% and 95.5%, respectively. At 9 months, freedom from CD-TLR and TVR were both 98.3%, while primary patency was 97.2% at 9 months. MAE occurred in 1.7% of patients.
Conclusions: In the AGILITY IDE iliac cohort, treatment with Revello™, a self-expanding covered stent, was associated with favorable safety and clinical outcomes through 9 months, including achievement of the pre-specified PG for the primary endpoint.
PERFORMANCE II Stroke Rates Through 1 Year: A Deep Dive Into Ipsilateral and Contralateral Stroke Outcomes by Subgroups
Presented by William A. Gray, MD
The PERFORMANCE II (PII) pivotal trial enrolled 305 subjects at high risk for CEA, both symptomatic and asymptomatic, to assess the safety and efficacy of the Neuroguard Integrated Embolic Protection (Neuroguard IEP) system in carotid artery stenting (CAS) using dual filtration and a purpose-built carotid stent. At 30 days there were 4 strokes (all minor), with 1 additional minor stroke at 1 year, and very low rates of target lesion revascularization.
We evaluated the outcomes in PII high-risk CAS sub-groups: symptomatic, age >75 years, and significantly calcified lesions. Separately, any contralateral stroke events are assessed.
Because of the low event rate in PII, statistical power was limited. However, there were no differences in outcomes between symptomatic and asymptomatic subjects, or between subjects >75 years or <75 years.
When outcomes by site-reported calcification grade were analyzed, there was a trend toward worse outcomes in higher grades of lesion calcium. However, when core lab-controlled assessments of calcium grade were used instead (where 2/3 of the subjects had moderate or severe lesion calcium), there were no differences in outcomes by calcium grade.
Lastly, there were no contralateral strokes reported in PII. Prior analysis from 2007 suggested a nearly 1% incidence.
The authors note that historical comparators with subset assessments are problematic due to incomplete data, lack of core lab adjudication, variable calcium scoring.
In conclusion, this subset analysis demonstrated an overall very low event rate, limiting analytic power. There was no outcome differentiation by at-risk lesion or participant characteristics, and no contralateral strokes, consistent with changes in CAS over time, especially refined patient selection. Post-hoc calcification analysis demonstrates gap between site-reported and core laboratory adjudicated calcification, with potential effects on outcome assessment
The Neuroguard IEP with double filtration appears to be performing as designed to reduce stroke risk for patients across all at-risk subgroups.
Treating Chronic Limb Ischemia Patients With Atherothrombectomy: Early Real-World Evidence From the Rotarex Global XTRACT Registry
Presented by Prakash Krishnan, MD
The XTRACT Registry is a prospective, multi-site, international, single-arm, real-world study evaluating the safety and effectiveness of the Rotarex™ Rotational Excisional Atherectomy System in patients with PAD (NCT07016698). This post-market registry will enroll approximately 600 patients in two separate cohorts: acute limb ischemia (ALI) and chronic limb ischemia (ChLI). Primary endpoints include freedom from composite of device- and/or procedure-related perioperative (≤ 30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post-index procedure, and procedural success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following the index procedure. Technical success is defined as reduction of residual stenosis and the successful creation of an optimal working channel allowing adjunctive therapies.
A total of 102 ChLI patients from nine investigational sites have been treated with Rotarex™ from Sept 2025 to June 2026, with enrollment ongoing. Subjects had a mean age of 69.7 years and 42.2% were female. The majority of subjects were Rutherford category 3 (37.3%) or 4 (34.3%). Over 20% of the patients had ≥ 2 target lesions treated with Rotarex™ (total of 130 lesions treated). The mean lesion length was 126.5mm, 54.6% de novo, and 26.9% in-stent restenosis, with 80.0% located in the SFA and 30.0% located in the popliteal artery. All 102 subjects had adjunctive procedures following Rotarex™, of which 18.5% had DCB and 91.5% had POBA. Technical success was 89.2%, with a low rate of device related distal embolization (0.98%), and 0% device related major flow limiting dissections. Primary safety, freedom from composite of device and/or procedural related complications through 30 days was 98.0%.
In this early interim analysis of the XTRACT Registry, treatment with the Rotarex™ system demonstrated high technical success and a low incidence of safety-related events (distal embolization and dissection) in a real-world PAD population. Ongoing enrollment and longer-term follow-up will further define outcomes across patient subgroups and lesion types.
About the VIVA Foundation
The VIVA Foundation is a nonprofit organization dedicated to advancing vascular medicine through education and research. Bringing together experts in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery, the Foundation provides multidisciplinary education designed to improve patient care and advance innovative therapies for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
SOURCE The VIVA Foundation
