Trials / Completed
CompletedNCT01372709
TriVascular Post-Market Registry
A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 501 (actual)
- Sponsor
- TriVascular, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ovation™ or Ovation Prime™ Abdominal Stent Graft System | Single occurrence permanent implant of AAA device. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-12-12
- Completion
- 2019-06-14
- First posted
- 2011-06-14
- Last updated
- 2021-06-04
Locations
30 sites across 8 countries: Austria, Belgium, France, Germany, Greece, Italy, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01372709. Inclusion in this directory is not an endorsement.