Talent Converter Post-Approval Study

Abdominal Aortic Aneurysms Clinical Trial

Official title:

Talent Converter Post-Approval Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01129609
• Other study ID #: Investigational Plan #119
• Status: Terminated
• Start date: April 2010
• Est. completion date: September 29, 2017

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 29, 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Successful Secondary Endovascular Treatment	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.	30 days