No phaseRecruitingAge-related condition
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)
- Sponsor
- Cook Research Incorporated (Industry)
- Enrolment
- 410 planned
- Conditions
- Peripheral Vascular Disease; Peripheral Arterial Disease
- Interventions
- Evero DCB; Paclitaxel DCB
- Ages
- adults, older adults
- Registry
- NCT07144150
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Primary safety endpoint
- Primary effectiveness endpoint
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered