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NCT01355406 · ClinicalTrials.gov registry record · NA
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
A NA study of Cardiovascular Diseases and Peripheral Artery Disease, sponsored by Cordis US.
- Completed
- Registry status
- NA
- Development phase
- 257
- Enrollment target
- 20
- Study locations
NCT01355406: Completed NA study of Cardiovascular Diseases and Peripheral Artery Disease, sponsored by Cordis US.
NCT01355406 is a NA study of Cardiovascular Diseases and Peripheral Artery Disease that has completed, run by Cordis US. The registered enrollment target is 257 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01355406, a NA study of Cardiovascular Diseases and Peripheral Artery Disease, has completed, sponsored by Cordis US.
- COMPLETED
- Registry status
- NA
- Development phase
- 257 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
Primary Outcome
The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.
Conditions Studied
Interventions
- DEVICE FlexStent® Femoropopliteal Self Expanding Stent System
Study Locations (20)
Florida
- Manatee Memorial Hospital - Bradenton
- Florida Research Network - Gainesville
- Memorial Hospital - Jacksonville
- Baptist Cardiac & Vascular Institute - Miami
- Mount Sinai Miami Medical Center - Miami Beach
- Florida Hospital Pepin Heart Institute - Tampa
Louisiana
- Lafayette General Medical Center - Lafayette
- Christus St. Patrick Hospital - Lake Charles
- Glenwood Regional Medical Center - West Monroe
Arizona
- Abrazo Health Care Clinical & Trans. Research - Phoenix
- Yuma Regional Medical Center - Yuma
New Jersey
- Deborah Heart - Browns Mills
- Cardiovascular Associates of the Delaware Valley - Haddon Heights
California
- El Camino Hospital - Mountain View
Connecticut
- Yale University/New Haven Hospital - New Haven
Georgia
- University Hospital - Augusta
Illinois
- St. John's Hospital - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2011-09-16 |
| Est. Completion | 2018-04-10 |
| Phase | NA |
What the finished NCT01355406 record still lists
NCT01355406 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which FlexStent® Femoropopliteal Self Expanding Stent System is the first listed.
NCT01355406 names 20 study sites across 11 states, led by Florida, Louisiana, Arizona.
Frequently Asked Questions
What is clinical trial NCT01355406 about?
NCT01355406 is a clinical study titled "Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System". This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the Fl...
What is the current status of trial NCT01355406?
This trial is currently completed. It is a NA study. The enrollment target is 257 participants. The study started on 2011-09-16. Estimated completion is 2018-04-10.
What conditions does trial NCT01355406 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, PAD.
What interventions are being tested in trial NCT01355406?
The interventions under investigation include: FlexStent® Femoropopliteal Self Expanding Stent System (DEVICE).
Who is sponsoring clinical trial NCT01355406?
This trial is sponsored by Cordis US, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01355406 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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 NCT01355406's enrollment target sits among peer trials
257 131st of 300 higher than 170 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases 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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