Trials / Terminated
TerminatedNCT01129609
Talent Converter Post-Approval Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary endpoint is successful secondary endovascular treatment with the Talent Converter stent graft of subjects having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. Treatment success is defined as a composite of successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit.
Detailed description
Converter PAS is an observational study. Patients will receive treatment regardless of study participation. In some cases, patients will be enrolled retrospectively, post implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System | All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2013-06-01
- Completion
- 2017-09-29
- First posted
- 2010-05-24
- Last updated
- 2021-10-29
- Results posted
- 2019-05-28
Source: ClinicalTrials.gov record NCT01129609. Inclusion in this directory is not an endorsement.