Evero everolimus-coated balloon versus paclitaxel-coated balloon for femoropopliteal PAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes adults with Rutherford class 2–4 peripheral arterial disease and de novo or non-stented restenotic lesions in the superficial femoral and/or popliteal arteries to receive either the Evero everolimus-coated balloon or a commercially available paclitaxel-coated balloon. It is a randomized, controlled non-inferiority design focused on long-term safety and effectiveness outcomes after angioplasty. Patients undergo the index percutaneous transluminal angioplasty procedure and then routine follow-up to monitor vessel patency and adverse events. Procedures and follow-up are conducted at the Cardiac and Vascular Institute in Gainesville, Florida.

Why it matters

Who can join: the full rules

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.

Where it's running

• Long Beach Veterans Administration Hospital/SCIRE Research
  Long Beach, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Medstar Georgetown University Hopsital
  Washington D.C., District of Columbia, United States Recruiting
• The Cardiac and Vascular Institute
  Gainesville, Florida, United States Recruiting
• First Coast Cardiovascular Institute
  Jacksonville, Florida, United States Recruiting
• Baptist Cardiac and Vascular Institute
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Noah Shields
• Email: noah.shields@cookmedical.com
• Phone: 765-463-7537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.