IN.PACT™ AV Access IDE Study

NCT03041467 | Completed Results DMC FDA Device

• 1 other identifier: APV-IN.PACT AV Access
• Study Type: interventional
• Target: 330
• Locations: 3 countries
• Sites: 29

Brief Summary

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.

Conditions

Arteriovenous Fistula Stenosis; Arteriovenous Fistula Occlusion; Arteriovenous Fistula; Fistula

Outcome Measures

Primary Outcomes (2)

• Target Lesion Primary Patency Rate Through 6 Months

  Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.

  6 Months Post-Procedure

• Primary Safety Endpoint - Serious Adverse Event Rate

  Serious Adverse Event (SAE) rate involving the AV access circuit

  30 days post procedure

Secondary Outcomes (17)

• Access Circuit Primary Patency

  3, 6, 9, 12, 18, and 24 Months

• Target Lesion Primary Patency

  3, 9, 12, 18, and 24 Months

• Cumulative Target Lesion Revascularizations

  3, 6, 9,12, 18, and 24 Months

• Total Number of Interventions Required to Maintain Target Lesion Patency

  3, 6, 9, 12, 18, and 24 Months

• Total Number of Interventions Required to Maintain Access Circuit Patency

  3, 6, 9, 12, 18, and 24 Months

Study Arms (2)

IN.PACT AV DCB

EXPERIMENTAL

PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."

Device: IN.PACT AV DCB

Standard Balloon Angioplasty

ACTIVE COMPARATOR

PTA will be performed using a commercially available uncoated PTA balloon.

Device: Standard Balloon Angioplasty

Interventions

IN.PACT AV DCB DEVICE

IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

IN.PACT AV DCB

Standard Balloon Angioplasty DEVICE

Standard PTA Balloon

Standard Balloon Angioplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (29)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35233, United States

Location

SKI Vascular Center

Tempe, Arizona, 85281, United States

Location

Capital Nephrology Medical Group

Sacramento, California, 95825, United States

Location

Florida Research Network

Gainesville, Florida, 32605, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

Christie Clinic Vein and Vascular Center

Champaign, Illinois, 61822, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

North Carolina Nephrology PA

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Sanford University of South Dakota Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37404, United States

Location

Dallas Nephrology Associates

Plano, Texas, 75093, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Richmond Vascular Center

North Chesterfield, Virginia, 23236, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

Kansai Rosai Hospital

Amagasaki, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Japan

Location

Saitama Medical Center Saitama Medical University

Saitama, Japan

Location

Shizuoka General Hospital

Shizuoka, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, Japan

Location

Auckland City Hospital

Auckland, New Zealand

Location

Capital and Coast District Health Board

Wellington, New Zealand

Location

Related Publications (1)

• Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A; IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020 Aug 20;383(8):733-742. doi: 10.1056/NEJMoa1914617.

  PMID: 32813949 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Phally Roffe, Clinical Study Manager
• Organization: Medtronic

phally.s.roffe@medtronic.com

763.526.0350

Study Officials

• Robert Lookstein, MD

  The Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

• Andrew Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Hiroaki Haruguchi, MD

  Haruguchi Vascular Access Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: April 25, 2017
• Primary Completion: December 6, 2018
• Study Completion: May 5, 2023
• Last Updated: May 29, 2024
• Results First Posted: February 27, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); JP (6); US (21)