AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Public ClinicalTrials.gov record NCT06029660. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06029660
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- IMPEDE-FX RapidFill Implants Device
- EndoVascular Aneurysm Repair Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 5, 2024 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Jul 2031 (Estimated)
- Last update posted
- Jul 10, 2026
2024 – 2031
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | — |
| Honor Health | Scottsdale | Arizona | 85258 | — |
| USC Keck | Los Angeles | California | 90033 | — |
| San Diego VA Medical Center | San Diego | California | 92161 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| Mt. Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Maine Medical | Portland | Maine | 04102 | — |
| Johns Hopkins | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| VA Ann Arbor Healthcare | Ann Arbor | Michigan | 48105 | — |
| Corewell Health | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| University at Buffalo | Buffalo | New York | 14203 | — |
| Buffalo VA Western New York | Buffalo | New York | 14215 | — |
| NYU Langone | New York | New York | 10016 | — |
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook Medicine | Stony Brook | New York | 11794 | — |
| TriHealth Heart Institute | Cincinnati | Ohio | 45242 | — |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Sanford Health | Sioux Falls | South Dakota | 57105 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| St. David's Healthcare | Austin | Texas | 78705 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Baylor Scott and White | Plano | Texas | 75093 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Inova Schar Heart and Vascular | Falls Church | Virginia | 22042 | — |
| Sentara Norfolk General | Norfolk | Virginia | 23507 | — |
| University of Wisconsin | Madison | Wisconsin | 53715 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06029660, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2026 · Synced Sep 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06029660 live on ClinicalTrials.gov.