IN.PACT™ AV Access Post-Approval Study (PAS002)

Long-term safety will be summarized

Study Overview

• Status: Recruiting
• Conditions: Fistula; Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Arteriovenous Fistula Occlusion
• Intervention / Treatment: Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort; Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort

Detailed Description

The purpose of this study is to evaluate the long-term safety of the IN.PACT™ AV Access Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. Patients will be followed for five years. The IN.PACT™ AV Access PAS 002 is required by the Food and Drug Administration (FDA) as a condition of product approval. This study is conducted within Medtronic's post market surveillance platform.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: PSR Study Team; Phone Number: 763-526-5668; Email: rs.productsurveillanceregistry@medtronic.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Heart Institute
      • Contact: Donald T Baril, MD
    • Stanford, California, United States, 94301
      • Recruiting
      • Stanford University Medical Center
      • Contact: Ronald Dalman, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • YALE New Haven Hospital
      • Contact: Britt Tonnessen, MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital
      • Contact: Nelson Bernardo, MD
  • Florida
    • Naples, Florida, United States, 34102
      • Recruiting
      • NCH Healthcare System
      • Contact: Alvaro J Zamora, MD, FACS
    • Pensacola, Florida, United States, 32504
      • Terminated
      • Coastal Vascular and Interventional
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Terminated
      • University of Iowa
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health System - University Hospital
      • Contact: Karthik Ramani, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Sanjay Misra, MD
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Holy Name Medical Center
      • Contact: John Rundback, MD
  • New York
    • Albany, New York, United States, 12084
      • Terminated
      • Albany Medical College
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Hospital
      • Contact: Kim Sung Yup, MD
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Staten Island University Hospital
      • Contact: Vincent Gallo, MD
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • FirstHealth of the Carolinas
      • Contact: Clint Atkinson, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University Hospital
      • Contact: Khashayar Farsad, MD
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Recruiting
      • Lancaster General Hospital
      • Contact: Meghan Dermody, MD
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • MUSC Health Dialysis Access Institute
      • Contact: John Aruny, MD
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Regional Medical Center
      • Contact: Ari Kramer, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia Medical Center
      • Contact: Daniel Sheeran, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53713
      • Recruiting
      • University of Wisconsin-Madison - Meriter Hospital
      • Contact: Micah Chan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients that will have an angioplasty with the IN.PACT™ AV Paclitaxel-Coated PTA Balloon Catheter (IN.PACT™ AV DCB).

Description

Primary Cohort Inclusion Criteria:

• Patient is ≥ 21 years of age
• Patient has a mature native AV fistula created ≥ 60 days prior to the index procedure
• Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction
• Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be included provided they meet all of the following criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combined lesion length, including 30 mm gap, ≤ 100 mm, c. 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 PTA balloon defined as: Residual stenosis of ≤ 30% AND Absence of a flow limiting dissection or perforation AND No extravasation requiring treatment

Primary Cohort 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 has an infected AV access or systemic infection
• Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
• 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
• Target lesion is located within a bare metal or covered stent
• 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 is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
• Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
• Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19

Inclusion Criteria for Extended Cohort:

• Patient is ≥ 21 years of age

Exclusion Criteria for Extended Cohort:

• Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IN.PACT™ AV Access PAS Primary Cohort; The primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort.	Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort; For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
IN.PACT™ AV Access PAS Extended Cohort; The extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit.	Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort; For treatment of stenosis in the AV circuit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection and Infestations Serious Adverse Events	Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.	Through 12 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Determine mortality rate	Through 1, 2, 3, 4, and 5 years post-index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extended Cohort - Characterize Infections and Infestations Serious Adverse Events	Characterize infections and infestations Serious Adverse Events, including pneumonia.	Through 1-year and all-cause mortality through 5-years post-index procedure

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: IN.PACT™ AV Access PAS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No