ZURICH, November 10, 2020 / PRNewswire / – Concept Medical Inc., a company focused on medical devices for drug delivery in vascular interventions, announced the enrollment of the first patient in the SirPAD clinical study ( Sir olimus in P eripheral A rtery D isease) (Sirolimus in peripheral arterial disease).
The SirPAD is the first randomized controlled clinical trial and for all who register , who will investigate major adverse events on limbs of patients with peripheral arterial disease with lesions below iguinal ligament.
SirPAD is a clinical study initiated by the investigator, carried out in a single, randomized, non-inferiority center and open to investigate whether the use of Sirolimus MagicTouch PTA coated balloon catheters in patients with peripheral arterial disease of the femoropopliteal segment or below the knee does not it is inferior to uncoated balloon catheters for the main clinical outcomes (major unplanned amputation, target limb revascularization). A total of 1,200 patients should be randomized 1: 1 (600 patients per treatment group).
The primary objective is to assess whether the use of sirolimus-coated balloon catheters ( MagicTouch PTA ) is not inferior to uncoated balloon catheters in infrainguinal angioplasty to prevent major adverse events in limbs within a year, including major unplanned amputation of the target limb and revascularization of the target lesion for critical limb ischemia, in a representative population of patients with peripheral arterial disease (“all who enroll”). If the non-inferiority criterion is confirmed, the study will test whether catheters coated with sirolimus ( MagicTouch PTA ) are superior to uncoated catheters in important secondary endpoints and for the primary endpoints themselves, according to pre-specified criteria for hierarchical analysis.
The first patient was successfully enrolled on 3 November 2020 at the Zurich University Hospital.
The study was started by Prof. Dr. Nils Kucher (also the principal investigator) in charge of the angiology clinic at the University Hospital in Zurich, Switzerland.
Prof. Dr. Nils Kucher was excited to start the study and said: “In the past decade, some controlled clinical studies have compared the efficacy and safety of drug-coated devices (mainly paclitaxel-coated) with uncoated devices, and have shown a significant reduction in restenosis rates, late lumen loss, and the incidence of revascularization of the target lesion, however, these studies were often too small to allow solid conclusions regarding the main clinical outcomes, in addition, the substantial heterogeneity of the study populations and the criteria very restrictive eligibility criterialimited their validity, causing difficulty in interpreting the meta-analysis. In fact, these studies have adopted representative (and quite subjective) results as the primary outcome, such as vessel patency and target limb revascularization, which may hinder objective judgment in the context of an open study, rather than objective clinical endpoints, such as amputation major or urgent revascularization due to critical limb ischemia. The objective of the SirPAD study is to compare the effectiveness, as defined by a combination of non-subjective outcomes (major amputation and revascularization of the target lesion due to critical limb ischemia), of sirolimus-coated balloon angioplasty vs. uncoated balloon for peripheral arterial disease in patients. “
Photo: https://mma.prnewswire.com/media/1329810/Enrolment_of_the_first_patient_in_the_SirPAD.jpg
Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg
SOURCE Concept Medical Inc.
