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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. Identifier: NCT03041467
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date September 6, 2019
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: September 4, 2019)
  • Primary Efficacy Endpoint - Target Lesion Primary Patency Rate [ Time Frame: 6 Months Post Procedure ]
    Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis
  • 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 Complete list of historical versions of study NCT03041467 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 Access DCB
    IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
  • Device: Standard Balloon Angioplasty Catheter
    Standard PTA Balloon
Study Arms  ICMJE
  • Experimental: IN.PACT AV Access DCB
    PTA will be performed using the IN.PACT AV Access drug coated balloon.
    Intervention: Device: IN.PACT AV Access DCB
  • Active Comparator: Standard Balloon Angioplasty Catheter
    PTA will be performed using a commercially available uncoated PTA balloon.
    Intervention: Device: Standard Balloon Angioplasty Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
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 has a life expectancy of ≥12 months
  2. Patient has a native AV fistula created ≥ 60 days prior to the index procedure
  3. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
  4. Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis
  5. Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate)
  6. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
  7. Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a high pressure PTA balloon

Exclusion Criteria:

  1. Patient is receiving immunosuppressive therapy
  2. Patient is anticipating a kidney transplant within 6 months of enrollment into the study
  3. Patient has undergone prior intervention of access site within 30 days of index procedure
  4. Patient with anticipated conversion to peritoneal dialysis
  5. Patient has an infected AV access or systemic infection
  6. Patient has planned surgical revision of access site
  7. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
  8. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
  9. Patient with target AVF or access circuit which previously had or currently has a thrombosis
  10. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
  11. Patient with target lesion located central to the axillosubclavian junction
  12. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
  13. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
  14. Patient has presence of a stent located in the target AV access circuit
  15. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
  16. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
  17. Patient with clinically significant Steal Syndrome requiring treatment
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 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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
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 Icahn School of Medicine at Mount Sinai
PRS Account Medtronic Endovascular
Verification Date September 2019

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