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EVERO Drug-coated Balloon (DCB) Randomized Trial

RecruitingNAAges 18 Years - anyAllCook Research Incorporated
NCT07144150 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Documented PAD with Rutherford classification 2 - 4; and 2. De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries. Exclusion Criteria: General Exclusion Criteria 1. Less than 18 years old; 2. Inability or refusal to give informed consent by the patient or legally authorized representative; 3. Life expectancy ≤ 12 months, per investigator assessment; 4. Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure; 5. Unable or unwilling to comply with the follow-up schedule; or 6. Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
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What it tests

  • Evero DCB
  • Paclitaxel DCB
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Where

12 sites
Long Beach Veterans Administration Hospital/SCIRE Research
Long Beach, United States
Yale New Haven Hospital
New Haven, United States
The Cardiac and Vascular Institute
Gainesville, United States
First Coast Cardiovascular Institute
Jacksonville, United States
Baptist Cardiac and Vascular Institute
Miami, United States
Midwest Cardiovascular Research Foundation
Davenport, United States
McLaren Bay Region Hospital
Bay City, United States
North Mississippi Medical Center
Tupelo, United States

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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