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New balloon device tested in 500 patients for leg artery and dialysis blockages

NCT ID NCT06687590

Disease control Sponsor: Cagent Vascular LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracks 500 people getting the Serranator balloon to open blocked leg arteries (peripheral artery disease) or dialysis fistulas. Doctors will check if the device works safely in everyday use. The goal is to improve blood flow without major complications.

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.

Participants

About 500 people

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

Started

Jan 2025

Expected to finish

Aug 2026

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.

Who is studied

The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.

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: * Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae. * Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb. * Age of subject is \> 18. * Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form. Exclusion Criteria: * Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion. * Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

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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.

Dysfunctional av fistula Dysfunctional av graft Peripheral artery disease (PAD)

How to take part

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

  1. The places running it

    18 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

  • Atlantic Medical Imaging

    RECRUITING

    Brick, New Jersey, 08724, United States

  • Aurora St. Luke's

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Barnes Jewish

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Brown Health

    RECRUITING

    Providence, Rhode Island, 02912, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Hartford HealthCare

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • HonorHealth

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Jefferson Einstein

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Manatee Memorial

    RECRUITING

    Bradenton, Florida, 34208, United States

  • MedStar Washington Hospital / MedStar Montgomery

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Miami Valley Hospital

    RECRUITING

    Dayton, Ohio, 45409, United States

  • Northwell

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health & Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn Presbyterian Medical Center

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33801, United States

  • Virtua Health

    RECRUITING

    Marlton, New Jersey, 08053, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.