Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
240 participants
OBSERVATIONAL
2020-11-13
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IN.PACT™ AV Access PAS Primary Cohort
The primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort.
IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
IN.PACT™ AV Access PAS Extended Cohort
The extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit.
IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
Interventions
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IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient is ≥ 21 years of age
Exclusion Criteria
* 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
* Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
21 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Heart Institute
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Medstar Washington Hospital
Washington D.C., District of Columbia, United States
NCH Healthcare System
Naples, Florida, United States
Coastal Vascular and Interventional
Pensacola, Florida, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Albany Medical College
Albany, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
MUSC Health Dialysis Access Institute
Orangeburg, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
University of Wisconsin-Madison - Meriter Hospital
Madison, Wisconsin, United States
Countries
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Other Identifiers
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IN.PACT™ AV Access PAS002
Identifier Type: -
Identifier Source: org_study_id
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