EVERO Drug-coated Balloon (DCB) Randomized Trial
Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)
Cook Research Incorporated
410 participants
Apr 17, 2026
INTERVENTIONAL
Conditions
Summary
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT07144150