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NCT05378347 · ClinicalTrials.gov registry record · NA
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
A NA study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), sponsored by Medtronic Cardiovascular.
- Recruiting
- Registry status
- NA
- Development phase
- 550
- Enrollment target
- 20
- Study locations
NCT05378347: Recruiting NA study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), sponsored by Medtronic Cardiovascular.
NCT05378347 is a NA study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder) that is actively recruiting participants, run by Medtronic Cardiovascular. The registered enrollment target is 550 participants, above the 419-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05378347, a NA study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), is actively recruiting participants, sponsored by Medtronic Cardiovascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
Primary Outcome
Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.
Conditions Studied
Interventions
- DEVICE Medtronic Endurant II or Endurant IIs Stent Graft System
- DEVICE Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Hoag Hospital - Newport Beach
- University of California Irvine Medical Center - Orange
- University of California Davis Medical Center - Sacramento
- University of California San Francisco UCSF Medical Center - San Francisco
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Sarasota Memorial Hospital - Sarasota
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Baystate Medical Center - Springfield
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
- Mayo Clinic Rochester - Rochester
Colorado
- Denver Health Medical Center - Denver
Connecticut
- Yale Center for Clinical Investigation - New Haven
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Georgia
- Northside Hospital Forsyth - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2031-05 |
| Phase | NA |
What NCT05378347 shows while recruiting
NCT05378347 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 419-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (31% higher).
The record links to 3 conditions, with Abdominal Aortic Aneurysm appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Endurant II or Endurant IIs Stent Graft System is the first listed.
NCT05378347 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05378347 about?
NCT05378347 is a clinical study titled "Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial". The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follo...
What is the current status of trial NCT05378347?
This trial is currently recruiting. It is a NA study. The enrollment target is 550 participants. The study started on 2023-01-05. Estimated completion is 2031-05.
What conditions does trial NCT05378347 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder).
What interventions are being tested in trial NCT05378347?
The interventions under investigation include: Medtronic Endurant II or Endurant IIs Stent Graft System (DEVICE), Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT05378347?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05378347 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Abdominal Aortic Aneurysm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05378347's enrollment target sits among peer trials
550 4th of 16 higher than 13 of 16 other Abdominal Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abdominal 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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