Talent Converter Post-Approval Study

October 27, 2021 updated by: Medtronic Cardiovascular

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Successful Secondary Endovascular Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Successful Secondary Endovascular Treatment
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Investigational Plan #119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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