Trials / Terminated
TerminatedNCT00444821
The (PIVOTAL) Study
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 728 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 40 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AneuRx AAA stent graft / Talent AAA stent graft | Catheter based stent graft inserted to seal off an abdominal aortic aneurysm |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2007-03-08
- Last updated
- 2021-10-11
- Results posted
- 2018-04-23
Locations
65 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00444821. Inclusion in this directory is not an endorsement.