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Trial record 1 of 3 for:    IN.PACT AV
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IN.PACT™ AV Access Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041467
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Results First Posted : February 27, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 2, 2017
Results First Submitted Date  ICMJE December 6, 2019
Results First Posted Date  ICMJE February 27, 2020
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE April 25, 2017
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Access Circuit Primary Patency [ Time Frame: 3, 6, 9 and 12 Months ]
    Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months and 12 months post-procedure. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Target Lesion Primary Patency [ Time Frame: 3, 9, and 12 Months ]
    Percent of subjects with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Cumulative Target Lesion Revascularizations [ Time Frame: 3, 6, 9, and 12 Months ]
    The proportion of subjects with target lesion revascularizations through 3 months, 6 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Total Number of Interventions Required to Maintain Target Lesion Patency [ Time Frame: 3, 6, 9 and 12 Months ]
    The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months and 12 months post-procedure. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Total Number of Interventions Required to Maintain Access Circuit Patency [ Time Frame: 3, 6, 9 and 12 Months ]
    The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Cumulative Access Circuit Thromboses [ Time Frame: 3, 6, 9 and 12 Months ]
    Proportion of subjects with access circuit thrombosis through 3 months, 6 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • 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 and 12 Months. ]
    Device Related Adverse Event Rate: defined as proportion of subjects with device related Adverse Events through 30 days, 3 months, 6 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
  • Procedure Related Adverse Event Rate [ Time Frame: 30 Days, 3, 6, 9 and 12 Months ]
    Procedure Related Adverse Event Rate: defined as proportion of subjects with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months and 12 months. Data for the 18 months and 24 months time points is ongoing. Results will be reported when analysis and collection is completed.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN.PACT™ AV Access Study
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Arteriovenous Fistula Stenosis
  • Arteriovenous Fistula Occlusion
  • Arteriovenous Fistula
  • Fistula
Intervention  ICMJE
  • Device: IN.PACT AV DCB
    IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
  • Device: Standard Balloon Angioplasty
    Standard PTA Balloon
Study Arms  ICMJE
  • 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."
    Intervention: Device: IN.PACT AV DCB
  • Active Comparator: Standard Balloon Angioplasty
    PTA will be performed using a commercially available uncoated PTA balloon.
    Intervention: Device: Standard Balloon Angioplasty
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
330
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2023
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 end. 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). Note: tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30 mm (3 cm), total combined lesion length, including 30 mm gap, is ≤ 100mm, and able to be treated as a single lesion
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041467
Other Study ID Numbers  ICMJE APV-IN.PACT AV Access
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Endovascular
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP