New balloon treatment aims to keep dialysis access open longer
NCT ID NCT04543539
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a special balloon coated with a drug to treat blockages in the blood vessels used for dialysis. The balloon is inflated inside the narrowed area to open it up and release medication that may help keep it from closing again. Researchers are following 240 adults with mature dialysis fistulas to check for serious infections and other safety issues over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- drug-coated balloon (paclitaxel)
- What this could lead to
- If successful, this could provide a safer and more effective way to keep dialysis fistulas open, reducing the need for repeat procedures.
- What could go wrong
- This is a post-approval study focused on long-term safety, not a new treatment. The drug coating may carry risks like infection, 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.
- Participants
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240 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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 includes patients that will have an angioplasty with the IN.PACT™ AV Paclitaxel-Coated PTA Balloon Catheter (IN.PACT™ AV DCB).
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Primary Cohort Inclusion Criteria: * Patient is ≥ 21 years of age * Patient has a mature native AV fistula created ≥ 60 days prior to the index procedure * Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction * Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be included provided they meet all of the following criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combined lesion length, including 30 mm gap, ≤ 100 mm, c. Able to be treated as a single lesion * Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate) * Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as: Residual stenosis of ≤ 30% AND Absence of a flow limiting dissection or perforation AND No extravasation requiring treatment Primary Cohort Exclusion Criteria: * Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children * Patient is receiving immunosuppressive therapy * Patient has an infected AV access or systemic infection * Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion * Patient with target lesion located central to the axillosubclavian junction * Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access * Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site * Target lesion is located within a bare metal or covered stent * Patients with known allergies or sensitivities to paclitaxel * Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated * Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy * Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study * Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation * Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19 Inclusion Criteria for Extended Cohort: * Patient is ≥ 21 years of age Exclusion Criteria for Extended Cohort: * Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albany Medical College
Albany, New York, 12084, United States
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Cedars-Sinai Heart Institute
Los Angeles, California, 90048, United States
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Coastal Vascular and Interventional
Pensacola, Florida, 32504, United States
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FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374, United States
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Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
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Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
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MUSC Health Dialysis Access Institute
Orangeburg, South Carolina, 29118, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Medstar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
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NCH Healthcare System
Naples, Florida, 34102, United States
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Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
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Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
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Stanford University Medical Center
Stanford, California, 94301, United States
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Staten Island University Hospital
Staten Island, New York, 10305, United States
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The Mount Sinai Hospital
New York, New York, 10029, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
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University of Wisconsin-Madison - Meriter Hospital
Madison, Wisconsin, 53713, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
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Other studies related to the condition(s) this trial covers.
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