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Talent Converter Post-Approval Study

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ClinicalTrials.gov Identifier: NCT01129609
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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.


Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms Device: Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Talent Converter Post-Approval Study
Study Start Date : April 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Group/Cohort Intervention/treatment
All Enrolled Subjects 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



Primary Outcome Measures :
  1. 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. [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects who are treated with the Talent Converter Stent Graft according to the indications for use
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.

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01129609     History of Changes
Other Study ID Numbers: Investigational Plan #119
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Medtronic Endovascular:
Post-approval observation of patients being treated according to the indications for use for the Talent Converter Stent Graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases