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Evero Drug-Coated Balloon for Peripheral Artery Disease

This study is testing a new treatment for peripheral arterial disease (PAD), a condition where narrowed arteries reduce blood flow to your limbs. It compares the Evero drug-coated balloon (DCB) to other commonly used paclitaxel DCBs. Both treatments involve a procedure called angioplasty (PTA) where a balloon is used to open blocked arteries in your legs. Researchers want to see if the Evero DCB is just as safe and effective as the paclitaxel DCBs for treating blockages in the superficial femoral and popliteal arteries. You might be able to join if you have PAD with a Rutherford classification of 2-4 and blockages in these specific arteries. The study will look at safety outcomes like death and amputation at 30 days and 12 months, and effectiveness at 12 months.

Study design
This is a randomized-controlled trial involving 410 participants. It compares the Evero DCB to paclitaxel DCBs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes at 30 days and 12 months, and for effectiveness at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07144150

EVERO Drug-coated Balloon (DCB) Randomized Trial

Recruiting
NAAges 18+InterventionalTreatment
Cook Research Incorporated
~410 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Evero DCBPaclitaxel DCB

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary safety endpoint
Measured over 30 days (death); 12 months (amputation and CD-TLR)
+1 more outcome measured

Conditions

Peripheral Vascular Disease
Peripheral Arterial Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

8 sites across 6 states
Florida3
Connecticut1
Iowa1
Mississippi1
South Carolina1
Texas1

Study leadership

  • Eric Secemsky, MD · STUDY_CHAIR · Beth Israel Deaconess Medical Center

Who to contact

Noah Shields
[email protected]
765-463-7537 · ext. 321174
Email the study team

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What this trial measures

  • Primary safety endpoint30 days (death); 12 months (amputation and CD-TLR)

    The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)

  • Primary effectiveness endpoint12 months

    The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.