IN.PACT™ AV Access IDE Study

NCT ID: NCT03041467

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2023-05-05

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.

Detailed Description

This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating 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. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IN.PACT AV DCB

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."

Group Type: EXPERIMENTAL

IN.PACT AV DCB

Intervention Type: DEVICE

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

Standard Balloon Angioplasty

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

Group Type: ACTIVE_COMPARATOR

Standard Balloon Angioplasty

Intervention Type: DEVICE

Standard PTA Balloon

Interventions

IN.PACT AV DCB

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

Intervention Type: DEVICE

Standard Balloon Angioplasty

Standard PTA Balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥21 years of age.

2. Patient has a life expectancy of ≥ 12 months

3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure

4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period

5. 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

6. 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

7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).

8. 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

9. Patient provides written consent prior to enrollment in the study

10. Patient is willing to comply with all follow-up evaluations at specified times

Exclusion Criteria

1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children

2. Patient is receiving immunosuppressive therapy

3. Patient is anticipating a kidney transplant within 6 months of enrollment into the study

4. Patient has undergone prior intervention of access site within 30 days of index procedure

5. Patient with anticipated conversion to peritoneal dialysis

6. Patient has an infected AV access or systemic infection

7. Patient has planned surgical revision of access site

8. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure

9. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion

10. Patient with target AVF or access circuit which previously had or currently has a thrombosis

11. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system

12. Patient with target lesion located central to the axillosubclavian junction

13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access

14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site

15. Patient has presence of a stent located in the target AV access circuit

16. Patients with known allergies or sensitivities to paclitaxel

17. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated

18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy

19. Patient with clinically significant Steal Syndrome requiring treatment

20. 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

21. 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Lookstein, MD

Role: PRINCIPAL_INVESTIGATOR

The Mount Sinai Hospital

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Hiroaki Haruguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Haruguchi Vascular Access Clinic

Locations

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

Shizuoka General Hospital

Shizuoka, , Japan

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Auckland City Hospital

Auckland, , New Zealand

Capital and Coast District Health Board

Wellington, , New Zealand

Countries

United States; Japan; New Zealand

References

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.

Reference Type: DERIVED

PMID: 32813949 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

APV-IN.PACT AV Access

Identifier Type: -

Identifier Source: org_study_id