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Talent Converter Post-Approval Study

NCT ID: NCT01129609

Last Updated: 2021-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-09-29

Brief Summary

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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

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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

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Abdominal Aortic Aneurysms

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants with Successful Secondary Endovascular Treatment

Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Investigational Plan #119

Identifier Type: -

Identifier Source: org_study_id