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New balloon could improve treatment for blocked leg arteries

NCT ID NCT07144150

Disease control Sponsor: Cook Research Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 10 times

Summary

This study compares a new balloon coated with everolimus to standard paclitaxel-coated balloons for opening blocked leg arteries in people with peripheral artery disease. About 410 participants will be randomly assigned to one of the two balloons. The goal is to see if the new balloon is as safe and effective at keeping arteries open after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus-coated balloon catheter
What this could lead to
If it works, this could offer a new treatment option for blocked leg arteries, potentially with fewer side effects than current drug-coated balloons.
What could go wrong
This is an early-stage comparison study, not a cure. The new balloon may not be as effective or safe as existing ones, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

intermittent vascular claudication peripheral arterial disease peripheral vascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease Peripheral vascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Cardiac and Vascular Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • First Coast Cardiovascular Institute

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • McLaren Bay Region Hospital

    RECRUITING

    Bay City, Michigan, 48708, United States

  • Midwest Cardiovascular Research Foundation

    RECRUITING

    Davenport, Iowa, 52801, United States

  • North Mississippi Medical Center

    RECRUITING

    Tupelo, Mississippi, 33801, United States

  • Prisma Health Memorial

    RECRUITING

    Greenville, South Carolina, 26905, United States

  • The Cardiac and Vascular Institute

    RECRUITING

    Gainesville, Florida, 32605, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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