Trials / Completed
CompletedNCT00507559
The Pivotal Study of the Aptus Endovascular AAA Repair System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
Detailed description
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aptus Endovascular AAA Repair System | EVAR (endovascular aneurysm repair) |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-03-01
- Completion
- 2014-05-01
- First posted
- 2007-07-26
- Last updated
- 2021-11-03
- Results posted
- 2016-05-27
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00507559. Inclusion in this directory is not an endorsement.