The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Everoâ„¢ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon \[DCB\]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
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Primary safety endpoint
Timeframe: 30 days (death); 12 months (amputation and CD-TLR)
Primary effectiveness endpoint
Timeframe: 12 months