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Active, not recruiting No phase listed Observational

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

ClinicalTrials.gov ID: NCT04543539

Public ClinicalTrials.gov record NCT04543539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 2:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Study identification

NCT ID
NCT04543539
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Medtronic
Industry
Enrollment
240 participants

Conditions and interventions

Interventions

  • IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort Combination Product
  • IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort Combination Product

Combination Product

Eligibility (public fields only)

Age range
21 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 12, 2020
Primary completion
Jun 2, 2025
Completion
Jan 31, 2029
Last update posted
Oct 19, 2025

2020 – 2029

United States locations

U.S. sites
20
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
Cedars-Sinai Heart Institute Los Angeles California 90048
Stanford University Medical Center Stanford California 94301
Yale New Haven Hospital New Haven Connecticut 06519
Medstar Washington Hospital Washington D.C. District of Columbia 20010
NCH Healthcare System Naples Florida 34102
Coastal Vascular and Interventional Pensacola Florida 32504
University of Iowa Iowa City Iowa 52242
University of Michigan Health System - University Hospital Ann Arbor Michigan 48109
Mayo Clinic Rochester Minnesota 55905
Holy Name Medical Center Teaneck New Jersey 07666
Albany Medical College Albany New York 12084
The Mount Sinai Hospital New York New York 10029
Staten Island University Hospital Staten Island New York 10305
FirstHealth of the Carolinas Pinehurst North Carolina 28374
Oregon Health & Science University Hospital Portland Oregon 97239
Lancaster General Hospital Lancaster Pennsylvania 17602
MUSC Health Dialysis Access Institute Orangeburg South Carolina 29118
Spartanburg Regional Medical Center Spartanburg South Carolina 29303
University of Virginia Medical Center Charlottesville Virginia 22903
University of Wisconsin-Madison - Meriter Hospital Madison Wisconsin 53713

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04543539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 19, 2025 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04543539 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →