Talent Converter Post-Approval Study

NCT01129609 | Terminated Results

• 1 other identifier: Investigational Plan #119
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

Post-approval observation of patients being treated according to the indications for use for the Talent Converter Stent Graft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants with Successful Secondary Endovascular Treatment

Device: Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

Interventions

Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System DEVICE

All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft

Participants with Successful Secondary Endovascular Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects who are treated with the Talent Converter Stent Graft according to the indications for use

You may qualify if:

• 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.
• Subjects who are able to understand the nature of the study and give voluntary informed consent.
• Subjects who are available for follow-up visits.
• Subjects 18 years of age or older.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

FDA allowed for early termination of the Talent Converter PAS because the device is no longer being manufactured, and exsisting inventory of the device has since expired, thus no statistical conclusions will be derived due to low enrollment.

Results Point of Contact

• Title: Rianna Rapson
• Organization: Medtronic

rianna.k.rapson@medtronic.com

763-526-2170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 24, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: September 29, 2017
• Last Updated: October 29, 2021
• Results First Posted: May 28, 2019

Record last verified: 2021-10