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NCT04261686 · ClinicalTrials.gov registry record · NA
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
A NA study of Arteriovenous Fistula, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 11
- Study locations
NCT04261686: Completed NA study of Arteriovenous Fistula, sponsored by C. R. Bard.
NCT04261686 is a NA study of Arteriovenous Fistula that has completed, run by C. R. Bard. The registered enrollment target is 100 participants, below the 220-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04261686, a NA study of Arteriovenous Fistula, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 11
- Study locations
Study Summary
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit.
Primary Outcome
Freedom from any adverse event(s), localized or systemic, that reasonably suggest the involvement of the AV access circuit that require or result in any of the following alone or in combination: additional interventions, in-patient hospitalization or prolongation of an existing hospitalization; or death.
Conditions Studied
Interventions
- DEVICE Covera Vascular Covered Stent
Study Locations (11)
Minnesota
- University of Minnesota Medical Center - Minneapolis
- Minnesota Vascular and Surgery Center - New Brighton
Texas
- Dallas Renal Group - Dallas
- San Antonio Kidney and Disease Access Center - San Antonio
Arizona
- Arizona Kidney Disease and Hypertension Center Medical Research Services - Phoenix
Connecticut
- Yale University - New Haven
Illinois
- Chicago Access Care - Westmont
Massachusetts
- Kidney Care & Transplant Services of New England - West Springfield
Michigan
- Michigan Vascular Center - Flint
North Carolina
- North Carolina Nephrology - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-07-03 |
| Est. Completion | 2025-09-16 |
| Phase | NA |
What the finished NCT04261686 record still lists
NCT04261686 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 220-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Arteriovenous Fistula appearing as the primary indexed condition, and to 1 intervention - of which Covera Vascular Covered Stent is the first listed.
NCT04261686 lists 11 locations in 9 states (Minnesota, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT04261686 about?
NCT04261686 is a clinical study titled "Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft". The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit.
What is the current status of trial NCT04261686?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2020-07-03. Estimated completion is 2025-09-16.
What conditions does trial NCT04261686 study?
This clinical trial studies the following conditions: Arteriovenous Fistula.
What interventions are being tested in trial NCT04261686?
The interventions under investigation include: Covera Vascular Covered Stent (DEVICE).
Who is sponsoring clinical trial NCT04261686?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04261686 being conducted?
This trial has 11 study locations across Arizona, Connecticut, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04261686's enrollment target sits among peer trials
100 7th of 8 higher than 2 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.
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