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NCT01534819 · ClinicalTrials.gov registry record
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
A clinical trial of Aortic Aneurysm, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- 1,090
- Enrollment target
- 20
- Study locations
NCT01534819: Active study of Aortic Aneurysm, sponsored by Medtronic Cardiovascular.
NCT01534819 is a study of Aortic Aneurysm that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 1,090 participants, above the 562-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534819, a study of Aortic Aneurysm, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- 1,090 participants
- Enrollment target
- 20
- Study locations
Study Summary
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.
Primary Outcome
The primary safety endpoint is defined by: i. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Conditions Studied
Interventions
- DEVICE EndoAnchor™
- PROCEDURE endovascular treament
Study Locations (20)
California
- VA Loma Linda Medical Center - Loma Linda
- El Camino Hospital - Mountain View
- University of California Irvine Medical Center - Torrance
- Harbor - UCLA Medical Center - Torrance
Florida
- Baptist Cardiac & Vascular Institute - Miami
- Florida Hospital - Orlando
- University of South Florida - Tampa
Illinois
- HeartCare Midwest - Peoria
- Evanston Hospital - Skokie
- Southern Illinois University - Springfield
Maryland
- University of Maryland Medical Center - Baltimore
- Johns Hopkins Bayview Medical Center - Baltimore
Alabama
- University of Alabama - Birmingham
Arizona
- Abrazo Arizona Heart Institute - Phoenix
Arkansas
- John L McClellan Memorial Veterans Hospital - Little Rock
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,090 participants |
| Start Date | 2012-04 |
| Est. Completion | 2026-04-24 |
What the registry record for NCT01534819 still lists
NCT01534819 is an observational study that tracks outcomes without assigning an intervention. Its 1,090 participants enrollment target places it among the larger protocols in the corpus, above the 562-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (94% higher).
The record links to 1 condition, with Aortic Aneurysm appearing as the primary indexed condition, and to 2 interventions - of which EndoAnchor™ is the first listed.
NCT01534819 names 20 study sites across 12 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01534819 about?
NCT01534819 is a clinical study titled "ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)". The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per loca...
What is the current status of trial NCT01534819?
This trial is currently active not recruiting. The enrollment target is 1,090 participants. The study started on 2012-04. Estimated completion is 2026-04-24.
What conditions does trial NCT01534819 study?
This clinical trial studies the following conditions: Aortic Aneurysm.
What interventions are being tested in trial NCT01534819?
The interventions under investigation include: EndoAnchor™ (DEVICE), endovascular treament (PROCEDURE).
Who is sponsoring clinical trial NCT01534819?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01534819 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01534819's enrollment target sits among peer trials
1,090 2nd of 14 the highest of 14 other Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm 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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