Clinical trial NCT03041467: IN.PACT™ AV Access IDE Study
Official title: Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula Stenosis
Arteriovenous Fistula Occlusion
Arteriovenous Fistula
Fistula
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2017-02-02
Enrollment: 330
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Target Lesion Primary Patency Rate Through 6 Months
timeFrame: 6 Months Post-Procedure
measure: Primary Safety Endpoint - Serious Adverse Event Rate
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Access Circuit Primary Patency
timeFrame: 3, 6, 9, 12, 18, and 24 Months
measure: Target Lesion Primary Patency
timeFrame: 3, 9, 12, 18, and 24 Months
measure: Cumulative Target Lesion Revascularizations
timeFrame: 3, 6, 9,12, 18, and 24 Months
measure: Total Number of Interventions Required to Maintain Target Lesion Patency
timeFrame: 3, 6, 9, 12, 18, and 24 Months
measure: Total Number of Interventions Required to Maintain Access Circuit Patency
timeFrame: 3, 6, 9, 12, 18, and 24 Months
measure: Cumulative Access Circuit Thromboses
timeFrame: 3, 6, 9, 12, 18, and 24 Months
measure: Device Success
timeFrame: Time of Procedure
measure: Procedure Success
timeFrame: Time of Procedure
measure: Clinical Success
timeFrame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
measure: Rate of Device Related Adverse Events
timeFrame: 30 days, 3, 6, 9, 12, 18, and 24 Months.
measure: Procedure Related Adverse Event Rate
timeFrame: 30 Days, 3, 6, 9, 12, 18, and 24 Months
measure: Target Lesion Revascularizations (TLR)
timeFrame: 6, 9, 12, 18, 24, and 36 Months
measure: Clinically-Driven Target Lesion Revascularizations (CD-TLR)
timeFrame: 6, 9, 12, 18, 24, and 36 Months
measure: Re-interventions in the Access Circuit
timeFrame: 6, 9, 12, 18, 24, and 36 Months
measure: Abandonment of Target AVF
timeFrame: 6, 9, 12, 18, 24, and 36 Months
measure: Serious Adverse Event Rate
timeFrame: 6, 12, 24, and 36 Months
measure: Rate of Freedom From All-Cause Mortality Post Vital Status Update
timeFrame: 6, 12, 24, 36, 48, and 60 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Tempe
country: United States
facility: SKI Vascular Center
state: Arizona
city: Sacramento
country: United States
facility: Capital Nephrology Medical Group
state: California
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Champaign
country: United States
facility: Christie Clinic Vein and Vascular Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Raleigh
country: United States
facility: North Carolina Nephrology PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Orangeburg
country: United States
facility: Dialysis Access Institute
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford University of South Dakota Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Plano
country: United States
facility: Dallas Nephrology Associates
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: North Chesterfield
country: United States
facility: Richmond Vascular Center
state: Virginia
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center Saitama Medical University
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Wellington
country: New Zealand
facility: Capital and Coast District Health Board
Study officials:
affiliation: The Mount Sinai Hospital
name: Robert Lookstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haruguchi Vascular Access Clinic
name: Hiroaki Haruguchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.