Talent Converter Post-Approval Study

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Talent Converter Post-Approval Study

Official Title

Talent Converter Post-Approval Study

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 Type

Observational

Primary Outcome

Number of Subjects With Successful Secondary Endovascular Treatment

Condition

Abdominal Aortic Aneurysms

Intervention

Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

Study Arms / Comparison Groups

 Participants with Successful Secondary Endovascular Treatment
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

20

Start Date

April 2010

Completion Date

September 29, 2017

Primary Completion Date

June 2013

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT01129609

Organization ID

Investigational Plan #119

Responsible Party

Sponsor

Study Sponsor

Medtronic Cardiovascular

Study Sponsor

, ,

Verification Date

October 2021