Trials / Active Not Recruiting
Active Not RecruitingNCT04751578
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Shape Memory Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IMPEDE-FX Embolization Plug | Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft |
Timeline
- Start date
- 2021-07-13
- Primary completion
- 2022-04-13
- Completion
- 2027-04-30
- First posted
- 2021-02-12
- Last updated
- 2025-12-22
Locations
3 sites across 1 country: Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04751578. Inclusion in this directory is not an endorsement.