Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Launched by MEDTRONIC CARDIOVASCULAR · Jan 16, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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