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NCT01726257 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
A NA study of Abdominal Aortic Aneurysm (AAA), sponsored by Endologix.
- Completed
- Registry status
- NA
- Development phase
- 333
- Enrollment target
- 20
- Study locations
NCT01726257: Completed NA study of Abdominal Aortic Aneurysm (AAA), sponsored by Endologix.
NCT01726257 is a NA study of Abdominal Aortic Aneurysm (AAA) that has completed, run by Endologix. The registered enrollment target is 333 participants, above the 78-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (327% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01726257, a NA study of Abdominal Aortic Aneurysm (AAA), has completed, sponsored by Endologix.
- COMPLETED
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
Primary Outcome
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss \>1,000cc
Conditions Studied
Interventions
- DEVICE Nellix System
Study Locations (20)
Florida
- Baptist Hospital of Miami - Miami
- Sacred Heart - Pensacola
Massachusetts
- St. Elizabeth's Medical Center - Brighton
- Bay State Hospital - Springfield
Ohio
- Cleveland Clinic - Cleveland
- Ohio Health Research Institute - Columbus
Arizona
- Tucson Medical Center - Tucson
California
- VA San Diego - San Diego
Connecticut
- Yale University - New Haven
Delaware
- Christiana Care Hospital - Newark
District of Columbia
- MedStar Health Research Institute - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2013-12 |
| Est. Completion | 2022-12 |
| Phase | NA |
What the finished NCT01726257 record still lists
NCT01726257 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (327% higher).
The record links to 1 condition, with Abdominal Aortic Aneurysm (AAA) appearing as the primary indexed condition, and to 1 intervention - of which Nellix System is the first listed.
NCT01726257 names 20 study sites across 17 states, led by Florida, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01726257 about?
NCT01726257 is a clinical study titled "Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System". The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
What is the current status of trial NCT01726257?
This trial is currently completed. It is a NA study. The enrollment target is 333 participants. The study started on 2013-12. Estimated completion is 2022-12.
What conditions does trial NCT01726257 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm (AAA).
What interventions are being tested in trial NCT01726257?
The interventions under investigation include: Nellix System (DEVICE).
Who is sponsoring clinical trial NCT01726257?
This trial is sponsored by Endologix, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01726257 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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