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NCT01680835 · ClinicalTrials.gov registry record · NA
EverFlex Post Approval Study
A NA study of Peripheral Arterial Disease and Lower Extremity Arterial Disease, sponsored by Medtronic Endovascular.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT01680835: Completed NA study of Peripheral Arterial Disease and Lower Extremity Arterial Disease, sponsored by Medtronic Endovascular.
NCT01680835 is a NA study of Peripheral Arterial Disease and Lower Extremity Arterial Disease that has completed, run by Medtronic Endovascular. The registered enrollment target is 108 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01680835, a NA study of Peripheral Arterial Disease and Lower Extremity Arterial Disease, has completed, sponsored by Medtronic Endovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
Primary Outcome
Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
Conditions Studied
Interventions
- DEVICE EverFlex™ Self-Expanding Peripheral Stent System
Study Locations (20)
Pennsylvania
- Lankenau Institute for Medical Research - Bryn Mawr
- Thomas Jefferson University - Philadelphia
- Allegheny General Hospital - Pittsburgh
California
- Memorial Medical Center - Modesto
- Sutter Memorial Hospital - Sacramento
Illinois
- DuPage Medical Group - Downers Grove
- Rockford Cardiovascular Associates - Rockford
South Dakota
- Black Hills Cardiovascular Research - Rapid City
- Sanford Research - Sioux Falls
Arizona
- St. Luke's Medical Center - Phoenix
Delaware
- Christiana Care Health Services - Newark
Florida
- First Coast Cardiovascular Institute, P.A. - Jacksonville
Georgia
- Augusta Vascular Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2013-01-14 |
| Est. Completion | 2019-02-04 |
| Phase | NA |
What the finished NCT01680835 record still lists
NCT01680835 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which EverFlex™ Self-Expanding Peripheral Stent System is the first listed.
NCT01680835 names 20 study sites across 15 states, led by Pennsylvania, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01680835 about?
NCT01680835 is a clinical study titled "EverFlex Post Approval Study". This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
What is the current status of trial NCT01680835?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2013-01-14. Estimated completion is 2019-02-04.
What conditions does trial NCT01680835 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease.
What interventions are being tested in trial NCT01680835?
The interventions under investigation include: EverFlex™ Self-Expanding Peripheral Stent System (DEVICE).
Who is sponsoring clinical trial NCT01680835?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01680835 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01680835's enrollment target sits among peer trials
108 37th of 79 higher than 42 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease 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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