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NCT04503395 · ClinicalTrials.gov registry record · NA
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
A NA study of Aortic Aneurysm, Abdominal, sponsored by FCRE (Foundation for Cardiovascular Research and Education).
- Recruiting
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 20
- Study locations
NCT04503395: Recruiting NA study of Aortic Aneurysm, Abdominal, sponsored by FCRE (Foundation for Cardiovascular Research and Education).
NCT04503395 is a NA study of Aortic Aneurysm, Abdominal that is actively recruiting participants, run by FCRE (Foundation for Cardiovascular Research and Education). The registered enrollment target is 204 participants, above the 129-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503395, a NA study of Aortic Aneurysm, Abdominal, is actively recruiting participants, sponsored by FCRE (Foundation for Cardiovascular Research and Education).
- RECRUITING
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
Primary Outcome
Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.
Conditions Studied
Interventions
- DEVICE ESAR treatment: Endograft + Heli-FX Endoanchor
- DEVICE FEVAR treatment : Fenestrated endograft
Study Locations (20)
Other
- Hospital Ottakring, Institute for Vascular Surgery - Vienna
- CRC thoracic Vascular Surgery, ZOL Genk - Genk
- Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde - Ghent
- Amrois Paré Hospital (APHP) - Boulogne
- Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert - Clermont-Ferrand
- Hospices Civils de lyon - Hôpital Edouard Herriot - Lyon
- Centre Hospitalier Universitaire de Rennes - Rennes
- University Hospital RWTH Aachen - Aachen
- University Hospital Leipzig - Leipzig
- Martin Austermann - Münster
California
- UCSD Medical Center Hillcrest - La Jolla
- Stanford University - Stanford
Florida
- University of Florida - Gainesville
Michigan
- Corewell Health (Spectrum) - Grand Rapids
New York
- Mount Sinai Hospital - New York
North Carolina
- Atrium Health Carolinas Medical Center - Charlotte
Oklahoma
- Oklahoma Heart - Tulsa
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2028-06-01 |
| Phase | NA |
What NCT04503395 shows while recruiting
NCT04503395 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, above the 129-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 2 interventions - of which ESAR treatment: Endograft + Heli-FX Endoanchor is the first listed.
NCT04503395 names 20 study sites across 10 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04503395 about?
NCT04503395 is a clinical study titled "ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES". The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aorti...
What is the current status of trial NCT04503395?
This trial is currently recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2021-05-21. Estimated completion is 2028-06-01.
What conditions does trial NCT04503395 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.
What interventions are being tested in trial NCT04503395?
The interventions under investigation include: ESAR treatment: Endograft + Heli-FX Endoanchor (DEVICE), FEVAR treatment : Fenestrated endograft (DEVICE).
Who is sponsoring clinical trial NCT04503395?
This trial is sponsored by FCRE (Foundation for Cardiovascular Research and Education), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04503395 being conducted?
This trial has 20 study locations across California, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04503395's enrollment target sits among peer trials
204 2nd of 8 the highest of 8 other Aortic Aneurysm, Abdominal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm, Abdominal 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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