IN.PACT™ AV Access Post-Approval Study (PAS002)
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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Long-term safety will be summarized
Study identification
- NCT ID
- NCT04543539
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Interventions
- IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort Combination Product
- IN.PACT™ AV Drug Coated Balloon (DCB) - Extended 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 13, 2020 (Actual)
- Primary completion
- Jun 3, 2025 (Actual)
- Completion
- Feb 2029 (Estimated)
- Last update posted
- Oct 20, 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 20, 2025 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04543539 live on ClinicalTrials.gov.