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Trial record 1 of 2 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
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Stenosis Arteriovenous Fistula Occlusion Arteriovenous Fistula Fistula Device: IN.PACT AV Access DCB Device: Standard Balloon Angioplasty Catheter Not Applicable

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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

MedlinePlus related topics: Angioplasty Fistulas

Arm Intervention/treatment
Experimental: IN.PACT AV Access DCB
PTA will be performed using the IN.PACT AV Access drug coated balloon.
Device: IN.PACT AV Access DCB
IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Active Comparator: Standard Balloon Angioplasty Catheter
PTA will be performed using a commercially available uncoated PTA balloon.
Device: Standard Balloon Angioplasty Catheter
Standard PTA Balloon




Primary Outcome Measures :
  1. 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

  2. Primary Safety Endpoint - Serious Adverse Event Rate [ Time Frame: 30 days post procedure ]
    Serious Adverse Event (SAE) rate involving the AV access circuit



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:

  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

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
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United States, Virginia
Richmond Vascular Center
North Chesterfield, Virginia, United States, 23236
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Robert Lookstein, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03041467     History of Changes
Other Study ID Numbers: APV-IN.PACT AV Access
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action