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NCT05484115 · ClinicalTrials.gov registry record · NA
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
A NA study of Aortic Aneurysm, Abdominal, sponsored by Rijnstate Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05484115: Recruiting NA study of Aortic Aneurysm, Abdominal, sponsored by Rijnstate Hospital.
NCT05484115 is a NA study of Aortic Aneurysm, Abdominal that is actively recruiting participants, run by Rijnstate Hospital. The registered enrollment target is 300 participants, above the 117-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05484115, a NA study of Aortic Aneurysm, Abdominal, is actively recruiting participants, sponsored by Rijnstate Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).
Primary Outcome
The primary endpoint is a composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from: 1. type IA endoleak and 2. Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) and 3. Aneurysm sac growth ≥5 mm (compared to 1-month imaging).
Conditions Studied
Interventions
- DEVICE endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
- DEVICE endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Study Locations (20)
Other
- HCL Lyon - Lyon
- Saint Joseph Marseille - Marseille
- Les Franciscaines - Nîmes
Michigan
- Henry Ford Hospital - Detroit
- Beaumont University Hospital - Royal Oak
Missouri
- University of Missouri - Columbia
- Barnes-Jewish Hospital - St Louis
New York
- Sisters of Charity hospital - Buffalo
- Stony Brook University Medical Center - Stony Brook
Arkansas
- Washington Regional Medical Center - Washington
Florida
- Mt Sinai Med Ctr - Miami Beach
Illinois
- Loyola - Maywood
Minnesota
- Alina Health - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-05-26 |
| Est. Completion | 2033-04 |
| Phase | NA |
What NCT05484115 shows while recruiting
NCT05484115 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 117-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (156% higher).
The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 2 interventions - of which endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system is the first listed.
NCT05484115 names 20 study sites across 15 states, led by Other, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT05484115 about?
NCT05484115 is a clinical study titled "Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck". The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck d...
What is the current status of trial NCT05484115?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-05-26. Estimated completion is 2033-04.
What conditions does trial NCT05484115 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.
What interventions are being tested in trial NCT05484115?
The interventions under investigation include: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (DEVICE), endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (DEVICE).
Who is sponsoring clinical trial NCT05484115?
This trial is sponsored by Rijnstate Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05484115 being conducted?
This trial has 20 study locations across Arkansas, Florida, Illinois, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05484115's enrollment target sits among peer trials
300 1st of 8 higher than 8 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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