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

Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)

This study will test whether an Everolimus-coated balloon works as safely and effectively as paclitaxel-coated balloons to open blockages in leg arteries for people with PAD and walking pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cook Group Incorporated (Industry-sponsored)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT07144150 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with PAD (Rutherford 2–4) who have de novo or non-stented restenotic lesions in the native superficial femoral and/or popliteal arteries and who can give informed consent and attend follow-up are ideal candidates.

Not a fit: Patients under 18, those with stented target lesions, limited life expectancy, pregnancy, inability to consent or comply with follow-up, or active participation in other investigational studies are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, patients may have an alternative drug-coated balloon using everolimus that provides similar artery-opening results with a different drug profile than paclitaxel.

How similar studies have performed: Paclitaxel-coated balloons have demonstrated effectiveness in femoropopliteal disease but raised safety questions, while everolimus-coated balloons are a newer approach with limited prior clinical data.

Eligibility criteria

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 this trial is running

Gainesville, Florida

• The Cardiac and Vascular Institute — Gainesville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Noah Shields

Conditions Peripheral Vascular Disease; Peripheral Arterial Disease; Intermittent claudication; Paclitaxel; Everolimus; Rapamycin; Drug-coated balloon; Percutaneous transluminal angioplasty