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NCT06029660 · ClinicalTrials.gov registry record · NA
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
A NA study of Aortic Aneurysm, Abdominal, sponsored by Shape Memory Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT06029660: Recruiting NA study of Aortic Aneurysm, Abdominal, sponsored by Shape Memory Medical.
NCT06029660 is a NA study of Aortic Aneurysm, Abdominal that is actively recruiting participants, run by Shape Memory Medical. The registered enrollment target is 180 participants, above the 132-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06029660, a NA study of Aortic Aneurysm, Abdominal, is actively recruiting participants, sponsored by Shape Memory Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
Primary Outcome
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
Conditions Studied
Interventions
- DEVICE IMPEDE-FX RapidFill Implants
- PROCEDURE EndoVascular Aneurysm Repair
Study Locations (20)
Florida
- Delray Medical Center - Delray Beach
- Orlando Health - Orlando
- University of South Florida - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham & Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
California
- USC Keck - Los Angeles
- San Diego VA Medical Center - San Diego
Michigan
- VA Ann Arbor Healthcare - Ann Arbor
- Corewell Health - Grand Rapids
Alabama
- University of Alabama Birmingham - Birmingham
Arizona
- Honor Health - Scottsdale
Georgia
- Emory University Hospital - Atlanta
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2031-06 |
| Phase | NA |
What NCT06029660 shows while recruiting
NCT06029660 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 2 interventions - of which IMPEDE-FX RapidFill Implants is the first listed.
NCT06029660 names 20 study sites across 14 states, led by Florida, Massachusetts, California.
Frequently Asked Questions
What is clinical trial NCT06029660 about?
NCT06029660 is a clinical study titled "AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion". To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for electi...
What is the current status of trial NCT06029660?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2024-04-05. Estimated completion is 2031-06.
What conditions does trial NCT06029660 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.
What interventions are being tested in trial NCT06029660?
The interventions under investigation include: IMPEDE-FX RapidFill Implants (DEVICE), EndoVascular Aneurysm Repair (PROCEDURE).
Who is sponsoring clinical trial NCT06029660?
This trial is sponsored by Shape Memory Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06029660 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06029660's enrollment target sits among peer trials
180 3rd of 8 higher than 6 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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