SUCCESS PTA Evaluates Cordis Selution SLR DEB at 24 Months

October 15, 2026—The 24-month data from the entire cohort of the SUCCESS PTA study were presented by Thomas Zeller, MD, in a late-breaking clinical trials session at VIVA 2026, the Vascular Interventional Advances conference.

As noted in the conference press release, SUCCESS PTA studied the safety and efficacy of the Selution SLR 018 sirolimus-eluting balloon (Cordis) in the treatment of real-world patients with peripheral artery disease (PAD).

The prospective, multicenter, single-arm postmarket study evaluated the Selution SLR for treatment of de novo/restenotic lesions in superficial femoral, popliteal, tibial, and pedal arteries.

The primary endpoint was 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. After 12 months, follow-up will be conducted yearly for up to 5 years, noted the VIVA summary.

The VIVA press release reported that the study enrolled 720 patients (males, 468 [65%]; mean age, 70.7 years) at 27 sites in Europe, Asia, and South America from February 2021 to October 2023.

Significant patient comorbidities included diabetes mellitus (273; 37.9%) and renal insufficiency (121; 16.8%); 186 patients (25.8%) presented with chronic limb-threatening ischemia (CLTI, Rutherford 4-6). The mean lesion length was 128.4 mm, 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.

The study’s 24-month outcomes showed clinical improvement associated with 86.1% freedom from CD-TLR overall and 83.0% for the CLTI subgroup.

As stated in the VIVA press release, the study concluded that the follow-up data highlight the consistency and durability of the Selution SLR drug-eluting balloon (DEB)’s safety and efficacy in treating real-world PAD patients.

These findings will contribute valuable evidence toward the expanding role of sirolimus-based DEBs in the endovascular management of PAD, noted the summary.