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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03041467
Other study ID # APV-IN.PACT AV Access
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2017
Est. completion date May 5, 2023

Study information

Verified date June 2023
Source Medtronic Endovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 330
Est. completion date May 5, 2023
Est. primary completion date December 6, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Device:
IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Standard Balloon Angioplasty
Standard PTA Balloon

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

United States,  Japan,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Primary Safety Endpoint - Serious Adverse Event Rate Serious Adverse Event (SAE) rate involving the AV access circuit 30 days post procedure
Secondary Access Circuit Primary Patency 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. 3, 6, 9, 12, 18, and 24 Months
Secondary Target Lesion Primary Patency 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. 3, 9, 12, 18, and 24 Months
Secondary Cumulative Target Lesion Revascularizations 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. 3, 6, 9,12, 18, and 24 Months
Secondary Total Number of Interventions Required to Maintain Target Lesion Patency 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. 3, 6, 9, 12, 18, and 24 Months
Secondary Total Number of Interventions Required to Maintain Access Circuit Patency 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. 3, 6, 9, 12, 18, and 24 Months
Secondary Cumulative Access Circuit Thromboses The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. 3, 6, 9, 12, 18, and 24 Months
Secondary Device Success 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. Time of Procedure
Secondary Procedure Success Maintenance of patency (=30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE). Time of Procedure
Secondary Clinical Success Resumption of successful dialysis for at least one session after index procedure. 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.
Secondary Rate of Device Related Adverse Events 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. 30 days, 3, 6, 9, 12, 18, and 24 Months.
Secondary Procedure Related Adverse Event Rate 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. 30 Days, 3, 6, 9, 12, 18, and 24 Months
Secondary Target Lesion Revascularizations (TLR) 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. 6, 9, 12, 18, 24, and 36 Months
Secondary Clinically-Driven Target Lesion Revascularizations (CD-TLR) 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 6, 9, 12, 18, 24, and 36 Months
Secondary Re-interventions in the Access Circuit 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. 6, 9, 12, 18, 24, and 36 Months
Secondary Abandonment of Target AVF Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure. 6, 9, 12, 18, 24, and 36 Months
Secondary Serious Adverse Event Rate 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. 6, 12, 24, and 36 Months
Secondary Rate of Freedom From All-Cause Mortality Post Vital Status Update 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. 6, 12, 24, 36, 48, and 60 Months
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