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
  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:


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
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.

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 October 02, 2014