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LAS VEGAS, Nov. 4, 2025 /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 four Late-Breaking Clinical Trial sessions at VIVA 2025, held at Wynn Las Vegas.
VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present the latest research and clinical data. The program is attended by interventional cardiologists, interventional radiologists, vascular surgeons, and specialists in endovascular medicine, providing unparalleled access to cutting-edge advances in vascular care.
Integrated Embolic Protection in TCAR: 30-Day Results From the PERFORMANCE III Trial
Presented by: Sean P. Lyden, MD
The PERFORMANCE III trial was a prospective, multicenter, open-label, single-arm study designed to evaluate the safety and effectiveness of the Neuroguard IEP System for TCAR in patients at high risk for adverse events with CEA. The system integrates a closed-cell nitinol stent, a semicompliant post-dilation balloon, and a 40-μm embolic filter into a single device on a 70-cm delivery system, used in conjunction with an embolic protection system providing flow reversal. Together, these features deliver dual neuroprotection while streamlining procedural steps.
A total of 146 patients were enrolled in the pivotal cohort across 26 sites. ITT analysis included 145 evaluable patients (mean age 70.5 years, 21% symptomatic, 39.7% diabetic). Nearly half (49.32%) of patients met anatomic high-risk criteria and 68.5% met physiologic high-risk criteria. Lesions were predominantly de novo, with a mean diameter stenosis of 82.6% and a moderate-to-severe calcification of 98.6%.
The primary endpoint was the rate of 30-day major adverse events (death, all stroke, and MI). One MAE occurred in 1/145 ITT subjects (0.69%, cardiac death); no strokes or neurological deaths were reported. The upper bound of the 95% CI (3.78%) was well below the prespecified performance goal of 11.0%, confirming the study objective was met.
Secondary endpoints included acute (98.6%), technical (99.3%), and procedural success (98.6%), with no reports of stroke (ipsilateral, major, or minor), CNI, stent thrombosis, or blood transfusion. Mean flow reversal time was 7.4 ± 3.5 minutes.
The PERFORMANCE III trial achieved its primary endpoint with a 30-day MAE rate of 0.69%. No strokes, neurological deaths, cranial nerve injuries, or transfusions were reported, and procedural success exceeded 98%. These outcomes build upon the favorable results of PERFORMANCE II and demonstrate very low 30-day event rates with TCAR-IEP using dual neuroprotection.
Prolonged Efficacy and Safety of a Drug-Eluting Resorbable Scaffold in CLTI: 3-Year Outcomes and Subgroup Analyses From the LIFE-BTK Trial
Presented by: Sahil A. Parikh, MD
The LIFE-BTK randomized controlled trial evaluates the long-term performance of the Esprit™ BTK drug-eluting resorbable scaffold (DRS) vs percutaneous transluminal angioplasty (PTA) in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease. This presentation highlights 3-year clinical outcomes and subgroup analyses.
At 3 years, DRS demonstrated a 33% relative improvement in the composite primary efficacy endpoint (primary patency and limb salvage) compared to PTA (59.5% vs 44.8%; P = .0025 log rank test). DRS was also associated with significantly lower rates of binary restenosis (38% vs 49%; P = .018 log rank test), and lower clinically driven target lesion revascularization rates, though the latter did not reach statistical significance (10.2% vs 18.4%; P = .052 log rank test). Safety outcomes, the composite of freedom from major adverse limb events at 3 years, and perioperative death at 30 days were similar between the 2 arms (90.8% vs 94.2%; P = .23 log rank test).
Subgroup analyses showed that the efficacy of DRS was consistent across most patient and lesion subgroups; however, significantly greater benefit was observed in patients with Rutherford-Becker class 4 disease and those not requiring inflow lesion treatment. Additional trends favoring DRS emerged in patients with none/mild calcification, mixed wound etiology, ‘Other’ race, and in those treated outside the United States.
These results support the Esprit BTK scaffold as a durable and effective endovascular treatment for CLTI, providing long-term vessel preservation, fewer reinterventions, and a comparable safety profile to PTA. The emerging subgroup signals also highlight the potential for personalized treatment strategies based on baseline clinical and anatomical characteristics.
One-Year Outcomes From the Disrupt PAD BTK II Study: Treatment of Patients With Calcified Below-the-Knee Lesions With a Peripheral Intravascular Lithotripsy System
Presented by: Ehrin Armstrong, MD
Background: Patients with calcified below-the-knee (BTK) lesions treated with intravascular lithotripsy (IVL) have demonstrated good acute results with high rates of procedural success and reduction in residual stenosis. The large population of real-world patients with calcified PAD in the Disrupt BTK II study provides a unique opportunity to assess 1-year outcomes in complex patients treated with IVL.
Materials and Methods: The prospective, single-arm Disrupt BTK II study enrolled 250 subjects of whom 200 were Rutherford category (RC) 4 or 5 and 50 were RC 3. Twelve-month endpoints included Kaplan-Meier (KM) estimates of freedom from clinically driven target lesion revascularization (CD-TLR) and major target limb amputation. Primary patency, change in RC, and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) scores were also assessed.
Results: Of 250 enrolled patients, 243 received IVL therapy; through 12 months, there were 30 deaths, 18 withdrawals from the study, and 2 subjects lost to follow-up. At 12 months, the rate of primary patency was 67.1%, KM freedom from CD-TLR was 84.5%, and KM freedom from major amputation was 94.8%. At baseline, 20%, 23%, and 57% of limbs were classified as RC 3, 4, and 5, respectively. At 12 months, RC was substantially improved as 48% were asymptomatic (RC 0), 15% reported only mild claudication (RC 1), and 78% had improved their RC. The mean improvement at 12 months in total VascuQoL-6 score was 6.0 ± 5.3 and 4.5 ± 5.7 for RC 3 and RC 4/5 patients, respectively.
Conclusions: Despite the very complex anatomies and comorbidities of patients with claudication or CLTI in the Disrupt PAD BTK II study, 1-year outcomes showed promising rates of revascularization and amputations, along with improvements in RC and QoL. These results support the use of IVL in the treatment of challenging patients with complex calcified BTK lesions
Novel Thrombectomy System for Acute Intermediate-Risk Pulmonary Embolism: Full Results From the Pivotal ENGULF Trial
Presented by: Andrew Klein, MD
The ENGULF study was a prospective, multicenter, single-arm trial evaluating the Hēlo Thrombectomy System for treating acute submassive pulmonary embolism. The trial enrolled 105 patients across 19 sites with 30 operators from multiple specialties (interventional cardiology, interventional radiology, and vascular surgery).
The study met both primary endpoints with statistical significance (P < .001). For effectiveness, patients demonstrated a 25.1% reduction in RV/LV ratio (0.4 absolute decrease) from baseline to 48 hours, exceeding the prespecified goal of >0.12 improvement. For safety, the major adverse event rate was 0.95% (1/105 patients), well below the prespecified goal of 25% based on literature, with no device-related deaths.
The Hēlo Thrombectomy System features an innovative design with continuous aspiration, a 24F clot engagement zone, and orbital agitator thrombectomy for clot remodeling to maintain a 15F heart crossing profile. Key procedural outcomes included a 39-minute device time and zero device corking incidents.
Secondary endpoints showed substantial clinical benefit: 16.6% reduction in systolic pulmonary artery pressure, 16.9% reduction in mean pulmonary artery pressure, and 16.2% reduction in Modified Miller score. The introduction of a blood return system during the trial reduced median blood loss from 340 mL to 10 mL, further completing the Hēlo platform.
The safety profile was excellent with no major bleeding, pulmonary vascular injury, or cardiac injury at 48 hours. At 30 days, all-cause mortality was 2.85%, device-related serious adverse events was 2.85%, and symptomatic PE recurrence was 3.80%.
Operator feedback during enrollment led to successful device iterations, resulting in a complete thrombectomy system with comparable pressure reduction to large-bore device trials while maintaining an exceptional safety profile and minimal blood loss.
STRIKE-PE: 1-Year Functional Outcomes and Quality of Life in Pulmonary Embolism Patients Treated With Computer-Assisted Vacuum Thrombectomy Using the 16F Catheter System
Presented by: John Moriarty, MD
Purpose: This analysis of the STRIKE-PE study reports functional outcomes and quality of life (QOL) at 1 year for pulmonary embolism (PE) patients treated with computer-assisted vacuum thrombectomy (CAVT) using the novel 16F catheter system.
Materials and Methods: STRIKE-PE is a single-arm, prospective, multicenter, ongoing trial designed for up to 1500 patients. Among the first 595 patients enrolled, 244 were treated with CAVT using the novel 16F catheter system. The primary endpoints of STRIKE-PE are change in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours and composite major adverse events (MAEs) at 48 hours. Functional outcomes and QOL were evaluated at 90 days and 1 year.
Results; Mean RV/LV ratio decreased from 1.34 at baseline to 0.95 at 48 hours (Δ 27.3%; P < .001). The composite MAE rate was 0.8% (2 patients). All functional outcomes were improved at 1 year; from 90 days to 1 year all improvements were sustained. Median Borg dyspnea scale at rest improved, decreasing from 4.0 at baseline to 0.0 at 1 year (P < .001). Mean 6-minute walk test distance increased from 222.5 meters at discharge to 370.7 meters at 1 year (P < .001). The NYHA classification distribution at 1 year recovered to that of before the PE event.
Mean EQ-5D-5L index value increased from 0.398 at baseline to 0.815 at 1 year (P < .001) and mean EQ-Visual Analogue Scale increased from 50.5 at baseline to 77.3 at 1 year (P < .001); these improvements were also sustained from 90 days to 1 year. Mean total PEmb-QoL improved, decreasing from 43.7 at baseline to 14.2 at 1 year (P < .001), a continued improvement from the 90-day result (P < .001).
Conclusions: In STRIKE-PE, patients treated with the 16F catheter system significantly improved their functional outcomes and QOL to 1 year. These findings demonstrate that treatment with CAVT using the 16F catheter system enhances patient outcomes and potentially reduces the long-term burden of PE-related sequelae.
Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation vs Anticoagulation Alone for Acute Intermediate- High-Risk PE: Primary Outcome, Functional Endpoints, and Core Lab Findings From STORM-PE
Presented by: Rachel Rosovsky, MD, MPH
STORM-PE is the first randomized controlled trial (RCT) to test the efficacy and evaluate the safety of mechanical thrombectomy using computer-assisted vacuum thrombectomy (CAVT) with anticoagulation (AC) vs AC alone in patients with acute intermediate-high-risk pulmonary embolism (PE). Functional endpoints, clinical parameters, and core lab findings were also analyzed.
Patients with acute (symptoms ≤14 days) intermediate-high-risk PE confirmed by a right-to-left ventricular (RV/LV) ratio ≥1.0 on CTPA and elevated cardiac biomarkers were randomized 1:1 to treatment with either CAVT + AC (CAVT arm) or AC alone (AC arm). The primary endpoint was the difference between groups in RV/LV ratio changes at 48 hours. Secondary endpoints include composite major adverse events (MAEs) within 7 days and functional assessments (eg, PVFS Scale, mMRC, Borg Scale, 6MWT). Core lab parameters included pulmonary artery (PA) obstruction index (MMS and RMMS) and IVC reflux. Clinical parameters included vital signs and National Early Warning Score 2 score (risk of clinical deterioration).
The reduction in RV/LV ratio was greater in the CAVT vs the AC arm (P < .001) with similar MAE rates (P = .681). The reduction of PA obstruction was also greater in the CAVT arm (P < .001). At 48 hours, less tachycardia and lower oxygen requirements were present in the CAVT arm vs the AC arm (2.2% vs 20.8%; P =.005 and 0.5 L/min vs 1.4 L/min; P =.027, respectively). Patients in the CAVT arm had a greater improvement in PVFS scores at discharge compared to the AC arm (P =.022).
In STORM-PE, the CAVT arm demonstrated superior reduction in RV dilatation with a similar safety profile to the AC arm. The CAVT arm also demonstrated functional assessment improvements, earlier physiological recovery, and greater reduction in PA obstruction vs the AC arm. These findings reinforce the role of mechanical thrombectomy as an effective treatment strategy in patients with acute intermediate-high-risk PE.
Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization (TCAR) in Standard-Risk Patients: 1-Year Outcomes of the ROADSTER 3 Study
Presented by: Meghan Dermody, MD
ROADSTER 3 was designed to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) using the ENROUTE stent in conjunction with the ENROUTE neuroprotection system (Boston Scientific) to treat standard-surgical-risk patients with extracranial internal carotid artery disease. In contrast to prior surveillance-based studies of TCAR procedures, ROADSTER 3 is prospective, with independent event adjudication and independent neurological assessments.
ROADSTER 3 is a prospective, multicenter, single-arm postapproval study. Patients aged <80 years without anatomic or physiologic high surgical risk factors were included. Between 2022 and 2024, 344 patients were prospectively enrolled at 48 sites in the United States. Of enrolled patients, 42.7% were female and 16.3% were symptomatic. The per-protocol population, which included 319 patients due to 25 patients with major protocol deviations, was the primary analysis population as required by the Food and Drug Administration. The primary endpoint was the hierarchical composite incidence of major adverse events defined as stroke, death, or myocardial infarction within 30 days and ipsilateral stroke from 31 to 365 days post procedure.
For the per-protocol population, the 30-day stroke/death/myocardial infarction rate was 0.6% (2/319). Two ipsilateral strokes occurred from 31 to 365 days post procedure (0.7%). The composite incidence of death, stroke, or myocardial infarction through 30 days and ipsilateral stroke from 31 to 365 days post procedure was 1.3% (4/305) for the per-protocol population. For the entire study population, there were strokes in 5 patients (1.5%; 5/329) with no instances of death or myocardial infarction within 30 days.
The primary results of the ROADSTER 3 study demonstrate safety and effectiveness of TCAR in the standard-risk population, based on prospective data with independent event adjudication and independent neurological assessment.
Potential for Sustained Abdominal Aortic Aneurysm Growth Stabilization After a Single Intra-Aortic Administration of Pentagalloylglucose: Clinical Evidence From a Phase I Study With the Nectero EAST® System
Presented by: Ramon L. Varcoe, MBBS, PhD
Study Design: Prospective, multicenter, OUS study of 46 patients with AAAs <5.5 cm in diameter. Patients were administered a one-time treatment of pentagalloylglucose (PGG) solution intra-arterially to the aneurysm with a weeping balloon over 3 minutes under infrarenal occlusion. Follow-up computed tomography angiography (CTA) was performed at 1, 2, and 3 years. Changes in maximum orthogonal AAA sac diameter were assessed by an independent core laboratory to determine growth. Annualized PGG-treated AAA growth rates were compared to expected natural history per Brady et al.1
Results: First-in-human (FIH) study results suggest an acceptable safety profile following local treatment with PGG solution. Mean baseline AAA maximum diameter was 42.7 mm (n=45). One-year follow-up data is available on the complete cohort of patients (n=44); there was a mean 70% reduction in AAA diameter growth from expected natural history. Complete follow-up data on the initial 21 patients is available (Phase Ia); average growth through 2 and 3 years was 2.5 mm (n=17) and 3.9 mm (n=14), respectively, representing a reduction from expected natural history growth of 56% through 2 years and 55% through 3 years.
Conclusions: A single administration of PGG may result in a sustained reduction of growth compared to expected natural history of small- to medium-sized AAAs and has the potential to significantly extend the time to OSR or EVAR conversion. These initial findings support further investigation in a randomized, controlled trial now underway.
1 Brady AR, et al. Abdominal aortic aneurysm expansion risk factors and time intervals for surveillance.
Circulation. 2004;110(1):16-21.
AGILITY: A Prospective, Multi-Center Evaluation of the BD Low Profile Vascular Covered Stent (Revello) in Peripheral Artery Disease
Presented by: Sean P. Lyden, MD
The AGILITY study is a global, prospective, multicenter, single-arm investigational device exemption (IDE) trial evaluating the Revello™ Vascular Covered Stent for treating complex peripheral artery disease (PAD) in the common/external iliac and superficial femoral artery (SFA)/ proximal popliteal artery (PPA). AGILITY will enroll 341 subjects across 45 global sites, divided into iliac (n = 118) and SFA/PPA (n = 223) cohorts. Each cohort’s primary endpoint is assessed against literature-based performance goals. The iliac cohort’s composite endpoint includes device/ procedure-related death or MI (30 days), CD-TLR, major amputation, or restenosis (9 months), while the SFA/PPA cohort focuses on freedom from major adverse events (30 days) and primary patency (12 months). Secondary endpoints include Rutherford category improvement, patency durability, quality of life (WOQ), and procedural success. Follow-up occurs at discharge, 30 days, 6 months (SFA/PPA only), 9 months (iliac only), and 12, 24, and 36 months. Initial results from 60 iliac patients show a mean age of 67 years (range: 48-88), 61.7% male. Lesions were 70% stenosed and 30% occluded, with 33.3% showing severe calcification. Mean lesion length was 45.7 mm (range: 10-170 mm), and angiographic classification included TASC C (16.7%) and D (11.7%) (NCT06111469).
Transcatheter Arterialization of the Deep Veins: Initial 6-Month Outcomes From the PROMISE III Trial
Presented by: Daniel Clair, MD
A subset of approximately 10% of patients with chronic limb-threatening ischemia (CLTI) have historically lacked viable options for conventional surgical or endovascular revascularization and face poor outcomes, including high major amputation rates. Transcatheter arterialization of the deep veins (TADV) with the purpose-built LimFlow System (Inari Medical, Irvine, CA) has demonstrated positive outcomes in no-option CLTI patients in the early feasibility PROMISE I trial and the pivotal PROMISE II trial. The PROMISE III trial is a continued-access, post-market study of the LimFlow System. This work reports the 6-month primary endpoint outcomes from the PROMISE III trial.
The PROMISE III trial is a prospective, multicenter, single-arm study of Rutherford class 5/6 CLTI patients who were confirmed ineligible for endovascular or surgical interventions by an independent physician review committee. Key exclusion criteria were 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. The primary endpoint was 6-month amputation-free survival (AFS), defined as freedom from both major (above-ankle) amputation of the index limb and all-cause mortality. Other endpoints included limb salvage, survival, wound status, and pain assessed through 6 months.
A total of 100 patients (103 limbs) underwent TADV between 2022 and 2024. All included limbs had nonhealing ulcers or gangrene with 75% Rutherford class 5 and 25% class 6. Technical success was 97%. At 6 months, the primary endpoint of AFS was 80.7%, limb salvage was 86.5%, and survival was 93.8%. Approximately 80% of wounds were completely healed or healing at 6 months. The median pain score was 2.0 at 6 months, significantly decreased from 6.0 at baseline (P < .0001).
The 6-month outcomes from the PROMISE III trial further reinforce the evidence for TADV with the LimFlow System for no-option CLTI.
Peripheral Retrievable Stent Therapy: DEEPER REVEAL Clinical Trial 6-Month Outcomes
Presented by: Mahmood Razavi, MD
Trial and Design: The DEEPER REVEAL trial is a prospective, single-arm, multicenter trial that enrolled 130 subjects in the United States, with in-person follow-up through 12 months post procedure. The study was designed to evaluate the safety and efficacy of a novel device, the Spur, a retrievable stent covered in circumferential spikes in patients with chronic limb-threatening ischemia (CLTI) of the infrapopliteal arteries. The device is an over-the-wire, 6-French–compatible system, which is inserted, deployed, and retrieved following treatment, leaving nothing behind.
Results: The majority of enrolled subjects had diabetes (74.6%), and more than 60% were Rutherford class 5; lesion characteristics showed a mean lesion length of 96.38 mm.
The primary endpoints, compared to performance goals, were met and previously reported. The primary efficacy endpoint of technical success (<30% residual stenosis) was 99.2% with one bailout stent, and freedom from the occurrence of MALE and perioperative death (POD) within 30 days post procedure was 96.9%.
At 6 months, secondary safety endpoints of freedom from MALE, limb salvage, and all-cause mortality (KM analysis) were 94.0%, 96.5%, and 4.7%, respectively.
Secondary efficacy endpoints at 6 months demonstrated primary patency by duplex ultrasound (75.3%), freedom from CD-TLR (85.5%), complete wound healing (74.2%), improvement in Rutherford class score (71.3%), and statistically significant improvement in quality of life scores from baseline.
Conclusions: In the DEEPER REVEAL study, primary safety and efficacy endpoints were met, demonstrating high rates of acute success compared to previous data with balloon angioplasty. Positive safety and clinical outcomes were demonstrated at 6 months, suggesting that acute success obtained with retrievable stent therapy may lead to long-term clinical improvements for patients with CLTI.
MOTIV BTK RCT: Safety and Effectiveness Study of the MOTIV Sirolimus-Eluting Bioresorbable Coronary Scaffold Compared with Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions–Primary Safety Endpoint
Presented by: Ehrin Armstrong, MD
The MOTIV device is a fully resorbable scaffold, manufactured from Tyrocore™, an iodinated, polycarbonate copolymer of tyrosine analogs. MOTIV is completely radiopaque, enabling precise edge-to-edge placement of multiple scaffolds for complete coverage of longer target lesions. The MOTIV BTK study is a prospective, multicenter, single-blind, randomized controlled trial that enrolled 292 subjects in the primary patient cohort presenting with Rutherford category 4 or 5 CLTI due to de novo lesions in native infrapopliteal arteries suitable for endovascular intervention. The study included treatment of lesions in vessels averaging 2.5-3.75 mm in diameter, with up to 2 lesions and a maximum total scaffold length of 120 mm permitted.
Subjects were randomized 1:1 (stratified by enrolling site and medically treated diabetes vs no medically treated diabetes) to one of 2 treatment arms (interventional–MOTIV or control–PTA with standard uncoated balloon). All subjects are undergoing clinical follow-up at 30 days, 6 months, and 1, 2, and 3 years. Duplex ultrasound (DUS) is being performed at 30 days, 6 months, and 1 year. Telephone follow-up will be conducted at 4 and 5 years.
A total of 68% of the patients were classified as Rutherford 5 with only 32% Rutherford 4. The average preintervention diameter stenosis was more than 89% with approximately 29% of the patients having moderate calcification. The average treated vessel diameter was 3.01 mm with an average target lesion length of 50.4 mm. All patients have completed their 30-day clinical follow-up visits.
The primary safety endpoint is defined as freedom from MALE and all-cause POD, evaluated at 30 days and defined as freedom from the composite of allcause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
In the MOTIV BTK study, the MOTIV sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable preliminary safety outcomes through the 30-day time point. Patient follow-up through a total of 5 years is ongoing and outcomes for the primary efficacy endpoint will be presented soon.
One-Year Outcomes From the FORWARD PAD IDE and Feasibility Studies of the Treatment of Calcified PAD With a Novel Forward Peripheral Intravascular Lithotripsy System
Presented by: Andrew Holden, MBChB
Background: Severe calcification, chronic total occlusions (CTOs), and medial calcification are obstacles for endovascular treatment of peripheral artery disease (PAD) and contribute to high mortality and amputation rates. In complex patients, current calcium modification technologies can be limited by an inability to deliver across severely stenosed lesions and associated risks of vessel damage and distal embolization. The novel Javelin intravascular lithotripsy (IVL) catheter uses acoustic pressure waves to safely modify calcification in extremely narrow crossing channels where other devices may be limited.
Methods: In the FORWARD PAD IDE and Feasibility Studies, 110 patients with 124 core lab-assessed lesions were enrolled. Twelve-month endpoints included major adverse events (MAEs), cardiovascular death, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and patency.
Results: Baseline lesion characteristics included 83.9% with severe calcification, diameter stenosis of 83.0 ± 17.4%, and 41.7% chronic total occlusions. At final angiography, patients had an acute gain of 2.8 ± 1.2 mm, residual stenosis of 23.1 ± 8.6%, and there was only one type D dissection. The 12-month overall rate of MAE was 18.6% (19/102), with 3.9% (4/102) of subjects experiencing cardiovascular death, 1.0% (1/102) with major amputation, and 14.7% (15/102) having CD-TLR. Primary, primary-assisted, and secondary patency in ATK lesions were 72.7%, 74.5%, and 76.4%, respectively. Primary, primary-assisted, and secondary patency in the BTK lesions were 61.5%, 78.4%, and 88.6%, respectively.
Conclusions: In heavily calcified and severely stenosed or completely occluded lesions, treatment with the Javelin IVL system resulted in stenosis reduction and acute gains without perforations or embolization consistent with the prior balloon-based IVL studies. The 1-year patency, amputation, and revascularization rates were comparable to prior clinical trials of heavily calcified lesions. Continued real-world assessments are ongoing to determine how the Javelin IVL catheter fits in the armamentarium of calcium-modifying technologies.
Results From Pulse IVL™ to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease: POWER PAD II
Presented by: D. Christopher Metzger, MD
Purpose: The POWER PAD II study is a prospective, multicenter, single-arm study to demonstrate the safety and effectiveness of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified, stenotic superficial femoral and popliteal (SFA/POP) arteries in patients with peripheral arterial disease. Eligibility criteria included moderate to heavily calcified SFA/POP arterial disease, Rutherford category 2 to 4 symptoms, reference vessel diameter 4 mm to 6.5 mm, and total lesion length of ≤150 mm.
Materials and Methods: Patients were enrolled at sites in the United States and followed for 6 months. The primary effectiveness endpoint is the proportion of patients who achieved a residual diameter stenosis of <50% post Pulse IVL procedure and after adjunctive therapy. The primary safety endpoint is freedom from major adverse events (MAEs) within 30 days from the Pulse IVL procedure, defined as emergency surgical revascularization of target limb, unplanned target limb amputation, symptomatic thrombus or distal emboli, or perforations or dissections of grade D or greater that require bailout stenting. An independent core lab adjudicated all angiograms at the time of the procedure, and an independent clinical events committee reviewed all adverse events.
Results: The POWER PAD II study is a US pivotal trial to examine the safety and efficacy of the AVS Pulse IVL System for treatment of severely calcified femoral and popliteal arterial disease.
Conclusions: In addition to the previously presented primary endpoints, we anticipate presenting results for unique subsets of patients.
Two-Year Clinical Outcomes From the Randomized-Controlled Arm of the WAVE Trial
Presented by: David J. Dexter, MD
Purpose: To summarize 24-month clinical outcomes following use of a novel cell-impermeable endoprosthesis (CIE) vs percutaneous transluminal angioplasty (PTA) to treat venous outflow obstructions in patients on hemodialysis.
Materials and Methods: A prospective, multicenter, international trial was conducted across 43 international centers. The randomized arm of the study included patients with venous outflow obstruction(s) in their arteriovenous fistula who were randomized 1:1 to treatment with the CIE or PTA. The primary safety endpoint was the proportion of patients without any localized or systemic safety events. The primary efficacy endpoint was the proportion of patients who achieved target lesion primary patency (TLPP) at 6 months. Access circuit primary patency (ACPP) was an additional efficacy measure of interest.
Results: A total of 245 patients were analyzed (CIE: n = 122; PTA: n = 123). The primary safety outcomes through 30 days were comparable for both interventions (CIE: 96.6%; PTA: 95.0%; noninferiority P < .0001). Device-related events were lower for the CIE vs PTA (2.9% vs 9.5%, P = .049). No significant differences in the proportion of patients experiencing serious adverse events were observed. Across all time points evaluated, TLPP has been significantly higher with the CIE vs PTA (6 months: 89.8% vs 62.8%, P < .0001; 12 months: 70.1% vs 41.6%, P < .0001). The CIE was associated with significantly higher ACPP at 6 months (72.6% vs 57.9%, P = .015) and 12 months (58.1% vs 34.4%, P = .0003). Findings at 24 months are pending.
Conclusions: The ability to prolong vascular access has important implications for physicians and patients. The 24-month outcomes from this study will address questions regarding the durability of clinical benefits associated with the CIE vs PTA.
Wearable, Noninvasive Therapeutic Ultrasound for Treatment of CLTI: A Sham-Controlled Randomized Controlled Trial
Presented by: Mahmood Razavi, MD
A randomized, double-blinded, crossover design clinical trial enrolled 29 Rutherford class 4-5 patients in 2:1 ratio to treatment with a wearable phased array of TUS transducers engineered to sonicate the posterior and anterior tibial arteries (and their collaterals) at the level of the calf vs sham therapy with an acoustically inert array of transducers. Patients underwent 30 treatments (active or sham) of 90 minutes with follow-up for 2 months after which active patients received another 15 treatments with 2-month follow-up to assess chronic changes. Endpoints included changes in Rutherford class, ankle- and toe-brachial indices (ABI/TBI), pedal tissue oxygenation (StO2) by spatial frequency domain imaging (Clarifi; Modulim), transcutaneous oximetry (TcPO2), and quantitative wound assessment. Per-protocol data are reported on the 23 patients who completed all TUS sessions and 9 patients who completed all sham sessions, and they were analyzed by paired t-tests and Chi-square analysis.
At baseline, 78% of patients were Rutherford class 4 and 22% were Rutherford class 5. After active TUS, 82% of patients were Rutherford classes 1-3 compared with only 22% of sham patients (P = .0012). TBI improved by 25% from 0.36 +/- 0.04 to 0.45 +/- 0.08 (P = .21) under active TUS with similar increases in toe pressure. Sham patients had no improvement in either TBI or toe pressure. Clarifi demonstrated a 24% increase in tissue oxygenation in the active TUS group compared with 6% decrease after sham (P = .15). There were no significant changes in TcPO2 in either group. Of the 5 patients with wounds undergoing active TUS, 3 demonstrated full wound healing and one had a reduction in wound size for a mean reduction in wound diameter of 71% from 28 +/- 10 to 8 +/- 11 mm. The 2 patients with wounds in the sham group had no improvement. Therapy was well tolerated by patients, and there were no serious adverse events.
Noninvasive TUS for CLTI patients was safe, well tolerated, and demonstrated improvements in Rutherford class and wound healing. Future studies will evaluate the potential for even longer-term therapy to increase efficacy.
36-Month Performance of a Sirolimus-Eluting Balloon in Diabetic and Nondiabetic Patients With Femoropopliteal Artery Disease From the SELUTION SFA Japan Study
Presented by: Ehrin Armstrong, MD
Background: Among patients with peripheral artery disease (PAD), those with diabetes mellitus (DM) represent a particularly high-risk group due to more aggressive atherosclerosis, smaller vessel diameters, and a higher risk for restenosis following endovascular interventions. Pathophysiologic differences and altered healing responses may lead to distinct outcomes between diabetic and nondiabetic patients.
Aim: The SELUTION SLR™ drug-eluting balloon (DEB) delivers sirolimus in a controlled, sustained manner, offering a favorable safety profile and a potential alternative to paclitaxel-based devices. This 36-month stratified analysis evaluates the performance of SELUTION SLR™ DEB in a Japanese population with and without DM.
Methods: The SELUTION SFA Japan (MDK-1901) study is a prospective, multicenter, single- arm trial that enrolled 134 patients across 13 Japanese sites. The primary endpoint was target lesion primary patency at 12 months. Patients were followed for 36 months; secondary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), thrombosis, and mortality.
Results: Of 134 enrolled patients, 79 (59%) had DM and 55 (41%) did not. At 36 months, Kaplan–Meier estimates showed freedom from TLR of 93.5% in the DM group and 94.3% in the non-DM group. Primary patency was 83.0% in DM patients vs 79.3% in non-DM patients. All-cause mortality was 2.8% in the DM group and 5.9% in the non-DM group.
Conclusion: SELUTION SFA Japan is the first study to assess SELUTION SLR™ DEB in a Japanese population. The 36-month data demonstrate durable efficacy and a favorable safety profile in femoropopliteal disease, with comparable outcomes in patients with and without DM. These findings strengthen the evidence for SELUTION SLR™ DEB as a long-term therapeutic option in PAD, highlighting its potential to address the needs of high-risk diabetic subgroups.
About the VIVA Foundation
The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
SOURCE The VIVA Foundation
