Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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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 or disease
Abdominal Aortic Aneurysms
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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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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