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Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00604643
First received: December 21, 2007
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.


Condition Intervention
Abdominal Aortic Aneurysms
 Device: TALENT Aortic Cuff Abdominal Stent Graft

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of the TALENT Aortic Cuff in the Treatment of Patients Previously Treated With the AneuRx Stent Graft System With Sub-Optimal Stent Graft Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Study Start Date: October 2002
Estimated Study Completion Date: April 2012
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: TALENT Aortic Cuff Abdominal Stent Graft
    Endovascular Aneurysm Repair
Detailed Description:

The primary purpose of this registry is to provide an endovascular means of treatment for those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an inadequate seal zone (< 1 cm). For Registry purposes, a Type III endoleak will be defined as a proximal modular endoleak.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient >= 18 years of age
  • Patient has a serious disease or condition
  • No generally acceptable alternative for treating patient is available
  • Patient has had the AneuRx stent graft system implanted >= 30 days
  • Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one or more of the following:
  • Type I endoleak
  • Type III endoleak (Proximal, modular)
  • Loss of seal zone
  • Proximal aortic neck diameter >= 14mm and <= 30mm
  • Angle between axis of the suprarenal aorta and aneurysm neck is <= 60 degrees
  • Patient is able and willing to be available for 12,24,26,48 and 60 months post-procedure

Exclusion Criteria:

  • Patient is pregnant of lactating
  • Arterial access cannot be crossed with a delivery system
  • Excessive vessel tortuosity
  • Excessive aortic calcification
  • AneuRx stent graft system implanted within the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604643

  Show 50 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Study Director: Medtronic CardioVascular Medtronic Cardiovascular
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604643     History of Changes
Other Study ID Numbers: Investigational Plan #025
Study First Received: December 21, 2007
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft

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

ClinicalTrials.gov processed this record on June 17, 2013