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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

December 21, 2007
January 16, 2013
October 2002
July 2008   (final data collection date for primary outcome measure)
Not Provided
Providing an endovascular means of treatment for patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated stent graft and who are unsuitable candidates for treatment with an AneuRx Aortic Cuff. [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00604643 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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

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.

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.

Expanded Access
Not Provided
Not Provided
Abdominal Aortic Aneurysms
Device: TALENT Aortic Cuff Abdominal Stent Graft
Endovascular Aneurysm Repair
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
April 2012
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604643
Investigational Plan #025
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Study Director: Medtronic CardioVascular Medtronic Cardiovascular
Medtronic Endovascular
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP