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New balloon could help dialysis patients avoid repeat procedures

NCT ID NCT03506308

Disease control Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a special balloon coated with medicine that is used to open up blocked dialysis fistulas in the arm. The goal is to see if it keeps the fistula working longer and safely. About 213 people took part in this global study.

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 213 people

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

Started

Aug 2018

Expected to finish

Apr 2030

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. Male or non-pregnant, non-breastfeeding female ≥18 years of age 2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits 3. Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines 4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU) 5. Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein 6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as: 1. No clinically significant dissection; 2. No extravasation requiring treatment; 3. Residual stenosis ≤30% by angiographic measurement; 4. Ability to completely efface the waist using the pre-dilation balloon. Exclusion Criteria: 1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study 2. Subject has a non-controllable allergy to contrast 3. Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up 4. Target lesion is located central to the axillosubclavian junction 5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure 6. Prior surgical interventions of the access site ≤30 days before the index procedure 7. Target lesion is located within a bare metal or covered stent

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Conditions

The condition(s) this trial relates to.

congenital arteriovenous fistula

As listed by the trial registrant

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

Arteriovenous fistula

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Centre hospitalier de l'Université de Montreal

    Montreal, Quebec, H2X 0C1, Canada

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dallas Vascular Center

    Dallas, Texas, 75208, United States

  • Flowers Hospital

    Dothan, Alabama, 36305, United States

  • HCA Houston Healthcare

    Houston, Texas, 77004, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Kaiser Permanente

    San Diego, California, 92123, United States

  • MedStar Health Research Institute

    Annapolis, Maryland, 21401, United States

  • Ochsner Health System

    New Orleans, Louisiana, 70121, United States

  • Ochsner Louisiana State University Health

    Shreveport, Louisiana, 71103, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Scarborough Health Network

    Scarborough Village, Ontario, M1P 2V5, Canada

  • Sentara Medical Group

    Norfolk, Virginia, 23507, United States

  • St. Joseph Hospital of Orange

    Orange, California, 92868, United States

  • University Health Network

    Toronto, Ontario, M5G 1Z5, Canada

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Health Science Center

    Houston, Texas, 77030, United States

  • William Osler Health System/Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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