Talent Converter Post-Approval Study

Terminated

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Device: Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

• Registration Number: NCT01129609
• Lead Sponsor: Medtronic Cardiovascular

Brief 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Primary Completion: 2013-06
• Study Completion: 2017-09-29
• Results First Submitted: 2019-02-07
• Results First Submitted QC: 2019-05-24
• Results First Posted: 2019-05-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subjects in whom a vessel access procedure was/will be performed with the attempted introduction of the Talent Converter Stent Graft for use according to the indications for use in the Instructions for Use (IFU) 0-365 days prior to enrollment.
2. Subjects who are able to understand the nature of the study and give voluntary informed consent.
3. Subjects who are available for follow-up visits.
4. Subjects 18 years of age or older.

Exclusion Criteria

1. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft other than (i.e., primary AUI) as a secondary endovascular intervention for patients having received prior endovascular repair with either a Talent or AneuRx bifurcated stent graft.
2. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft as a secondary endovascular intervention for patients having received prior endovascular repair with a bifurcated stent graft other than (i.e., Cook Zenith or Gore Excluder) a Talent or AneuRx bifurcated stent graft.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Successful Secondary Endovascular Treatment	Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Successful Secondary Endovascular Treatment	30 days	The outcome measure is successful secondary endovascular treatment with the Talent Converter stent graft where treatment success is defined as 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.