Talent Converter Post-Approval Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01129609
First received: April 29, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Abdominal Aortic Aneurysms
Device: Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Talent Converter Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 89
Study Start Date: April 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01129609     History of Changes
Other Study ID Numbers: Investigational Plan #119
Study First Received: April 29, 2010
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014