IN.PACT™ AV Access IDE Study

Completed · Not applicable

Conditions studied: Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula

In brief

To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.

Key facts

Study ID: NCT03041467
Run by: Medtronic Endovascular
People needed: 330
Starts: 2017-04-25
Expected to finish: 2023-05-05
Last updated by the study team: 2024-05-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is ≥21 years of age.
Patient has a life expectancy of ≥ 12 months
Patient has a native AV fistula created ≥ 60 days prior to the index procedure
The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. If the lesion is located in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein
Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including 30 mm gap, ≤ 100 mm, and 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 high pressure PTA balloon defined as: residual stenosis of ≤ 30% and absence of a flow limiting dissection (Grade ≥ C) or perforation
Patient provides written consent prior to enrollment in the study
Patient is willing to comply with all follow-up evaluations at specified times

You may not qualify if…

Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
Patient is receiving immunosuppressive therapy
Patient is anticipating a kidney transplant within 6 months of enrollment into the study
Patient has undergone prior intervention of access site within 30 days of index procedure
Patient with anticipated conversion to peritoneal dialysis
Patient has an infected AV access or systemic infection
Patient has planned surgical revision of access site
Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
Patient with target AVF or access circuit which previously had or currently has a thrombosis
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
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
Patient has presence of a stent located in the target AV access circuit
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 with clinically significant Steal Syndrome requiring treatment
Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study
Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound data interpretation

Where it is running

University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
SKI Vascular Center — Tempe, Arizona, United States
Capital Nephrology Medical Group — Sacramento, California, United States
Florida Research Network — Gainesville, Florida, United States
Coastal Vascular and Interventional — Pensacola, Florida, United States
Christie Clinic Vein and Vascular Center — Champaign, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
King's Daughters Medical Center — Ashland, Kentucky, United States
Mayo Clinic — Rochester, Minnesota, United States
Holy Name Medical Center — Teaneck, New Jersey, United States
The Mount Sinai Hospital — New York, New York, United States
North Carolina Nephrology PA — Raleigh, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Dialysis Access Institute — Orangeburg, South Carolina, United States
Sanford University of South Dakota Medical Center — Sioux Falls, South Dakota, United States
University Surgical Associates — Chattanooga, Tennessee, United States
Dallas Nephrology Associates — Plano, Texas, United States
Sentara Vascular Specialists — Norfolk, Virginia, United States
Richmond Vascular Center — North Chesterfield, Virginia, United States
Vascular Institute of Virginia — Woodbridge, Virginia, United States
Kansai Rosai Hospital — Amagasaki, Japan
Shonan Kamakura General Hospital — Kamakura, Japan
Kishiwada Tokushukai Hospital — Kishiwada, Japan
Saitama Medical Center Saitama Medical University — Saitama, Japan

Full record on ClinicalTrials.gov

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