IN.PACT™ AV Access IDE Study

Not Applicable

Completed

Conditions: Arteriovenous Fistula Occlusion
Arteriovenous Fistula
Fistula
Arteriovenous Fistula Stenosis

Interventions: Device: IN.PACT AV DCB
Device: Standard Balloon Angioplasty

Registration Number: NCT03041467

Lead Sponsor: Medtronic Endovascular

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 330

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN.PACT AV DCB	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."
Standard Balloon Angioplasty	Standard Balloon Angioplasty	PTA will be performed using a commercially available uncoated PTA balloon.

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency Rate Through 6 Months	6 Months Post-Procedure	Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Primary Safety Endpoint - Serious Adverse Event Rate	30 days post procedure	Serious Adverse Event (SAE) rate involving the AV access circuit

Secondary Outcome Measures

Name	Time	Method
Access Circuit Primary Patency	3, 6, 9, 12, 18, and 24 Months	Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Target Lesion Primary Patency	3, 9, 12, 18, and 24 Months	Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Cumulative Target Lesion Revascularizations	3, 6, 9,12, 18, and 24 Months	The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Device Success	Time of Procedure	Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
Clinical Success	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.	Resumption of successful dialysis for at least one session after index procedure.
Cumulative Access Circuit Thromboses	3, 6, 9, 12, 18, and 24 Months	The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Total Number of Interventions Required to Maintain Access Circuit Patency	3, 6, 9, 12, 18, and 24 Months	The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.
Procedure Related Adverse Event Rate	30 Days, 3, 6, 9, 12, 18, and 24 Months	Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Clinically-Driven Target Lesion Revascularizations (CD-TLR)	6, 9, 12, 18, 24, and 36 Months	Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure
Total Number of Interventions Required to Maintain Target Lesion Patency	3, 6, 9, 12, 18, and 24 Months	The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.
Target Lesion Revascularizations (TLR)	6, 9, 12, 18, 24, and 36 Months	Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Re-interventions in the Access Circuit	6, 9, 12, 18, 24, and 36 Months	Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Abandonment of Target AVF	6, 9, 12, 18, 24, and 36 Months	Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure.
Serious Adverse Event Rate	6, 12, 24, and 36 Months	Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.
Procedure Success	Time of Procedure	Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Rate of Freedom From All-Cause Mortality Post Vital Status Update	6, 12, 24, 36, 48, and 60 Months	Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
Rate of Device Related Adverse Events	30 days, 3, 6, 9, 12, 18, and 24 Months.	Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Trial Locations

Locations (29): Vascular Institute of Virginia
🇺🇸
Woodbridge, Virginia, United States
SKI Vascular Center
🇺🇸
Tempe, Arizona, United States
Coastal Vascular and Interventional
🇺🇸
Pensacola, Florida, United States
University Surgical Associates
🇺🇸
Chattanooga, Tennessee, United States
Christie Clinic Vein and Vascular Center
🇺🇸
Champaign, Illinois, United States
University of Alabama at Birmingham (UAB) Hospital
🇺🇸
Birmingham, Alabama, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
The Mount Sinai Hospital
🇺🇸
New York, New York, United States
King's Daughters Medical Center
🇺🇸
Ashland, Kentucky, United States
North Carolina Nephrology PA
🇺🇸
Raleigh, North Carolina, United States
Dallas Nephrology Associates
🇺🇸
Plano, Texas, United States
Richmond Vascular Center
🇺🇸
North Chesterfield, Virginia, United States
Sentara Vascular Specialists
🇺🇸
Norfolk, Virginia, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Capital Nephrology Medical Group
🇺🇸
Sacramento, California, United States
Florida Research Network
🇺🇸
Gainesville, Florida, United States
Kansai Rosai Hospital
🇯🇵
Amagasaki, Japan
Kishiwada Tokushukai Hospital
🇯🇵
Kishiwada, Japan
Saitama Medical Center Saitama Medical University
🇯🇵
Saitama, Japan
Tokyo Women's Medical University Hospital
🇯🇵
Tokyo, Japan
Shonan Kamakura General Hospital
🇯🇵
Kamakura, Japan
Shizuoka General Hospital
🇯🇵
Shizuoka, Japan
Auckland City Hospital
🇳🇿
Auckland, New Zealand
Holy Name Medical Center
🇺🇸
Teaneck, New Jersey, United States
Dialysis Access Institute
🇺🇸
Orangeburg, South Carolina, United States
Sanford University of South Dakota Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Capital and Coast District Health Board
🇳🇿
Wellington, New Zealand