Trials / Recruiting
RecruitingNCT06029660
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Shape Memory Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IMPEDE-FX RapidFill Implants | Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants |
| PROCEDURE | EndoVascular Aneurysm Repair | Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent. |
Timeline
- Start date
- 2024-04-05
- Primary completion
- 2027-06-01
- Completion
- 2031-06-01
- First posted
- 2023-09-08
- Last updated
- 2025-12-09
Locations
45 sites across 5 countries: United States, France, Netherlands, New Zealand, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06029660. Inclusion in this directory is not an endorsement.