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NCT04543539 · ClinicalTrials.gov registry record
IN.PACT™ AV Access Post-Approval Study (PAS002)
A clinical trial of Arteriovenous Fistula and Fistula, sponsored by Medtronic.
- Active
- Registry status
- 240
- Enrollment target
- 20
- Study locations
NCT04543539: Active study of Arteriovenous Fistula and Fistula, sponsored by Medtronic.
NCT04543539 is a study of Arteriovenous Fistula and Fistula that is active but no longer recruiting, run by Medtronic. The registered enrollment target is 240 participants, above the 203-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04543539, a study of Arteriovenous Fistula and Fistula, is active but no longer recruiting, sponsored by Medtronic.
- ACTIVE NOT RECRUITING
- Registry status
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
Long-term safety will be summarized
Primary Outcome
Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.
Conditions Studied
Interventions
- COMBINATION_PRODUCT IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
- COMBINATION_PRODUCT IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
Study Locations (20)
New York
- Albany Medical College - Albany
- The Mount Sinai Hospital - New York
- Staten Island University Hospital - Staten Island
California
- Cedars-Sinai Heart Institute - Los Angeles
- Stanford University Medical Center - Stanford
Florida
- NCH Healthcare System - Naples
- Coastal Vascular and Interventional - Pensacola
South Carolina
- MUSC Health Dialysis Access Institute - Orangeburg
- Spartanburg Regional Medical Center - Spartanburg
Connecticut
- Yale New Haven Hospital - New Haven
District of Columbia
- Medstar Washington Hospital - Washington D.C.
Iowa
- University of Iowa - Iowa City
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2029-02 |
What the registry record for NCT04543539 still lists
NCT04543539 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (18% higher).
The record links to 4 conditions, with Arteriovenous Fistula appearing as the primary indexed condition, and to 2 interventions - of which IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort is the first listed.
NCT04543539 names 20 study sites across 15 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04543539 about?
NCT04543539 is a clinical study titled "IN.PACT™ AV Access Post-Approval Study (PAS002)". Long-term safety will be summarized
What is the current status of trial NCT04543539?
This trial is currently active not recruiting. The enrollment target is 240 participants. The study started on 2020-11-13. Estimated completion is 2029-02.
What conditions does trial NCT04543539 study?
This clinical trial studies the following conditions: Arteriovenous Fistula, Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion.
What interventions are being tested in trial NCT04543539?
The interventions under investigation include: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort (COMBINATION_PRODUCT), IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04543539?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04543539 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arteriovenous Fistula
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04543539's enrollment target sits among peer trials
240 4th of 8 higher than 5 of 8 other Arteriovenous Fistula trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arteriovenous Fistula trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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