O-211 - INTERIM REPORT OF THE SUCCESS PTA STUDY EVALUATING SAFETY AND EFFICACY OF THE NOVEL SIROLIMUS-ELUTING SELUTION SLR BALLOON IN PERIPHERAL ARTERIAL DISEASE

TOPIC:
Peripheral Occlusive Arterial Disease
AUTHORS:
Lichtenberg M. ( Klinikum Hochsauerland GmbH ~ Arnsberg ~ Germany)
Introduction:
SUCCESS PTA Study is a real-world, prospective, multi-center, single arm post market surveillance study of the novel SELUTION SLR 018 sirolimus-eluting balloon for treatment of de novo/ restenotic lesions in superficial femoral artrey (SFA), popliteal, tibial and/or pedal arteries. SELUTION SLR (M.A. MedAlliance S.A., Nyon, Switzerland) is a novel CE-marked drug-coated balloon incorporating non-crystaline sirolimus embedded in biodegradable polymer micro-reservoirs, providing sustained sirolimus release out to 90 days and allowing for low drug dose of 1 µg/mm2. Pre-clinical studies have confirmed that resulted particulates were small and homogenous in size as opposed to balloons with Crystalline paclitaxel formulations and regardless of the vascular bed, no injury related to downstream embolization was observed. Initial Clinical outcomes in first-in-man studies as well as complex patients has confirmed the absence of slow-flow phenomenon and the long-term safety & efficacy profile of the SELUTION SLR. The objective of the SUCCESS 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.
Methods:
A minimum of 722 subjects are planned to be recruited at 50 sites in Europe, Asia, Canada, and South America, in an all-comers fashion. The primary endpoint of the study is freedom from clinically driven target lesion revascularization (cd-TLR) at 1-year. Follow ups are planned at 1, 6, 12 months and then yearly up to 5 years. Major secondary endpoints are device and procedural success, Major Adverse Limb Events (MALE) defined as severe limb ischemia leading to an intervention or major vascular amputation (above the ankle), death, amputation, changes in the Rutherford score, change in ankle brachial index, and wound status if applicable. This is an interim analysis of the first 100 patients enrolled in the study with at least 6-month follow-up.
Results:
The study is currently recruiting and has enrolled over 200 patients between Feb 2021 and Mar 2022. 100 patients will have 6 month follow up available by the time of the presentation. The 1-month and 6-month outcomes of this cohort will be reported.
Conclusion:
This is the first report of the SUCCESS PTA study in the largest cohort treated with SELUTION SLR 018 to date.