IN.PACT™ AV Access Study
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| ClinicalTrials.gov Identifier: NCT03041467 |
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Recruitment Status :
Active, not recruiting
First Posted : February 2, 2017
Results First Posted : February 27, 2020
Last Update Posted : August 16, 2022
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Sponsor:
Medtronic Endovascular
Information provided by (Responsible Party):
Medtronic Endovascular
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arteriovenous Fistula Stenosis Arteriovenous Fistula Occlusion Arteriovenous Fistula Fistula | Device: IN.PACT AV DCB Device: Standard Balloon Angioplasty | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | April 25, 2017 |
| Actual Primary Completion Date : | December 6, 2018 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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."
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Device: IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon |
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Active Comparator: Standard Balloon Angioplasty
PTA will be performed using a commercially available uncoated PTA balloon.
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Device: Standard Balloon Angioplasty
Standard PTA Balloon |
Primary Outcome Measures :
- Number of Participants With Target Lesion Primary Patency Though 6 Months [ Time Frame: 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 [ Time Frame: 30 days post procedure ]Serious Adverse Event (SAE) rate involving the AV access circuit
Secondary Outcome Measures :
- Access Circuit Primary Patency [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Total Number of Interventions Required to Maintain Target Lesion Patency [ Time Frame: 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.
- Total Number of Interventions Required to Maintain Access Circuit Patency [ Time Frame: 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.
- Cumulative Access Circuit Thromboses [ Time Frame: 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.
- Device Success [ Time Frame: 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.
- Procedure Success [ Time Frame: Time of Procedure ]Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
- Clinical Success [ Time Frame: 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.
- Rate of Device Related Adverse Events [ Time Frame: 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.
- Procedure Related Adverse Event Rate [ Time Frame: 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.
- Target Lesion Revascularizations (TLR) [ Time Frame: 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.
- Clinically-Driven Target Lesion Revascularizations (CD-TLR) [ Time Frame: 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
- Re-interventions in the Access Circuit [ Time Frame: 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 [ Time Frame: 6, 9, 12, 18, 24, and 36 Months ]Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 end. 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041467
Locations
Show 29 study locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
| Principal Investigator: | Robert Lookstein, MD | The Mount Sinai Hospital | |
| Principal Investigator: | Andrew Holden, MD | Auckland City Hospital | |
| Principal Investigator: | Hiroaki Haruguchi, MD | Haruguchi Vascular Access Clinic |
Study Documents (Full-Text)
Documents provided by Medtronic Endovascular:
Documents provided by Medtronic Endovascular:
Study Protocol [PDF] January 20, 2022
Statistical Analysis Plan [PDF] February 7, 2022
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Endovascular |
| ClinicalTrials.gov Identifier: | NCT03041467 |
| Other Study ID Numbers: |
APV-IN.PACT AV Access |
| First Posted: | February 2, 2017 Key Record Dates |
| Results First Posted: | February 27, 2020 |
| Last Update Posted: | August 16, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Additional relevant MeSH terms:
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Arteriovenous Fistula Fistula Pathological Conditions, Anatomical Arteriovenous Malformations Vascular Malformations |
Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities |