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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)

Who can join

Ages 18 and older · All sexes

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.

About the study

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).

What is being tested

• Evero DCB (combination product)
• Paclitaxel DCB (combination product)

Sponsor: Cook Research Incorporated · Participants: 410 · Started: Apr 17, 2026

Contact the study team

• Noah Shields · Phone: 765-463-7537

Official record on ClinicalTrials.gov — NCT07144150

Locations in the U.S.

Conditions

• Peripheral Arterial Disease
• Intermittent Claudication

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.