Comparing Evero Everolimus-Coated Balloon and Paclitaxel-Coated Balloons for Treating Blockages in Leg Arteries Due to Peripheral Arterial Disease

What this Trial Is About

Researchers are studying the long-term safety and effectiveness of the Advance Evero18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter Evero drug-coated balloon for treating femoropopliteal artery lesions in patients with peripheral arterial disease PAD. The trial compares the Evero drug-coated balloon to commercially available paclitaxel-coated balloons to show that Evero is not less safe or effective. This is a randomized controlled trial designed to assess these outcomes in patients with PAD needing treatment in specific leg arteries. Participants will receive treatment with either the Evero drug-coated balloon delivering everolimus or a commercially available balloon coated with paclitaxel. Both treatments involve percutaneous transluminal angioplasty PTA targeting de novo or restenotic lesions in the native superficial femoral and popliteal arteries. The study is double-blinded and participants are randomly assigned to one of these two treatment groups. During the study, participants will be followed for safety and effectiveness outcomes, including death at 30 days and amputation or clinically driven target lesion revascularization within 12 months. The primary effectiveness endpoint is also measured at 12 months. The trial will monitor participants closely to collect these outcome data and ensure adherence to follow-up schedules. The study is expected to run until October 2032, with primary completion in September 2028.

EVERO Drug-coated Balloon (DCB) Randomized Trial