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NCT01257438 · ClinicalTrials.gov registry record · NA
FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
A NA study of Restenosis, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 275
- Enrollment target
- 20
- Study locations
NCT01257438: Completed NA study of Restenosis, sponsored by C. R. Bard.
NCT01257438 is a NA study of Restenosis that has completed, run by C. R. Bard. The registered enrollment target is 275 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01257438, a NA study of Restenosis, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 275 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.
Primary Outcome
Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.
Conditions Studied
Interventions
- DEVICE Fluency Plus Endovascular Stent Graft
- DEVICE Percutaneous Transluminal Angioplasty only
Study Locations (20)
Arizona
- Southwest Kidney Institute Inc - Phoenix
- Arizona Kidney Disease & Hypertension Center-Surgery Center - Phoenix
- Capital Nephrology Access Center - Sacramento
- Angiocare LLC w/Renal Care Associates PC - Tucson
California
- Greater Long Beach Vascular Access Center - Bellflower
- Ladenheim Dialysis Access Centers - Fresno
Connecticut
- American Access Care Connecticut Image Guided Surgery - Fairfield
- Yale University - New Haven
Georgia
- Vascular & Interventional Care Center - Augusta
- Savannah Vascular Surgery - Savannah
Alabama
- University of Alabama Radiology Dept - Birmingham
Florida
- First Coast Cardiovascular Institute - Jacksonville
Illinois
- MakrisMD, LLC, d/b/a Chicago Access Care - Hinsdale
Massachusetts
- The Vascular Access Center - West Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2010-12 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT01257438 record still lists
NCT01257438 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Restenosis appearing as the primary indexed condition, and to 2 interventions - of which Fluency Plus Endovascular Stent Graft is the first listed.
NCT01257438 names 20 study sites across 14 states, led by Arizona, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01257438 about?
NCT01257438 is a clinical study titled "FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis". The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access ...
What is the current status of trial NCT01257438?
This trial is currently completed. It is a NA study. The enrollment target is 275 participants. The study started on 2010-12. Estimated completion is 2016-01.
What conditions does trial NCT01257438 study?
This clinical trial studies the following conditions: Restenosis.
What interventions are being tested in trial NCT01257438?
The interventions under investigation include: Fluency Plus Endovascular Stent Graft (DEVICE), Percutaneous Transluminal Angioplasty only (DEVICE).
Who is sponsoring clinical trial NCT01257438?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01257438 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01257438's enrollment target sits among peer trials
275 383rd of 2000 higher than 1,616 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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