Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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.
|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|
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||April 2012|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Device: TALENT Aortic Cuff Abdominal Stent Graft
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.
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|Study Director:||Medtronic CardioVascular||Medtronic Cardiovascular|