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New balloon could save legs from amputation in artery disease trial

NCT ID NCT06182397

Disease control Sponsor: Concept Medical Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special balloon coated with sirolimus, a drug that helps keep arteries open, versus a standard balloon for people with severe leg artery disease below the knee. About 368 adults with advanced symptoms like pain at rest or non-healing wounds will be randomly assigned to one of the two treatments. The goal is to see if the drug-coated balloon better prevents re-blockage, avoids major amputation, and improves blood flow over 12 months.

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 368 people

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

Started

Jan 2025

Expected to finish

Feb 2031

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

21 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. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations) 2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population. 3. Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria: 4. Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure. 5. Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery) Exclusion Criteria: 1. Comorbid conditions limiting life expectancy ≤ 1 year 2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet 3. Subject is lactating, pregnant or planning to become pregnant during the course of the study 4. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with: 1. Osteomyelitis including and/or proximal to the metatarsal head 2. Gangrene involving the plantar skin of the forefoot, midfoot,or heel 3. Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel 4. Full thickness heel ulcer with/without calcaneal involvement 5. Any wound with calcaneal bone involvement 6. Wounds that are deemed to be neuropathic or non-ischemic in nature 7. Wounds that would require flap coverage or complex wound management for large soft tissue defect 8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone 5. Prior bypass surgery of target vessel 6. Planned amputation of the target limb (major) 7. Previously implanted stent in the target lesion 8. Vulnerable or protected adults 9. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents 10. Known allergy to sirolimus 11. Subjects with severe (Stage 4) renal disease, defined eGFR \< 30. Intraoperative exclusion criteria: 12. Failure to successfully cross the target lesion with a guide wire 13. Target vessel has lesions extending beyond the ankle joint 14. Failure to obtain \<30% residual stenosis prior to randomization 15. Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach. 16. Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

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

Arterial disease of legs Below-the-knee obstruction Pad - peripheral arterial disease

How to take part

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

  1. The places running it

    29 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

  • Ascension Seton Medical Center Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • Atria Vascular and Vein

    NOT_YET_RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Baptist Hospital of Miami

    RECRUITING

    Miami, Florida, 33176, United States

  • Baylor Research Institute

    RECRUITING

    Dallas, Texas, 75226, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Clearwater Cardiovascular Consultants

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Columbia University Irving Medical center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Deborah Heart and Lung Center

    RECRUITING

    Browns Mills, New Jersey, 08015, United States

  • HOPE Vascular and Podiatry

    RECRUITING

    Houston, Texas, 77054, United States

  • Honor Health Research & Innovation Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Lankenau Institute for Medical Research Bryn Mawr Hospital

    RECRUITING

    Bryn Mawr, Pennsylvania, 19010, United States

  • Medical University of South Carolina(MUSC) Health Ashley River Tower

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NYU Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery

    RECRUITING

    New York, New York, 10065, United States

  • Northwell Health Long Island Jewish Medical Center

    RECRUITING

    Lake Success, New York, 11042, United States

  • San Antonio Vascular and Endovascular Clinic

    NOT_YET_RECRUITING

    San Antonio, Texas, 78221, United States

  • St. Francis Hospital and Heart Center

    NOT_YET_RECRUITING

    Roslyn, New York, 11576, United States

  • The Christ Hospital Network Outpatient Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Unity Point Health Des Moines

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Pennsylvania - Penn Heart and Vascular Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Washington Seattle

    RECRUITING

    Seattle, Washington, 98104, United States

  • Vascular Institute of the Midwest

    RECRUITING

    Davenport, Iowa, 52807, United States

  • Virtua Healthcare - Virtua Our Lady of Lourdes

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

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