Brief Title
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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
Brief Summary
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.
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.
Study Type
Expanded Access
Condition
Abdominal Aortic Aneurysms
Intervention
TALENT Aortic Cuff Abdominal Stent Graft
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medtronic CardioVascular, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00604643
Organization ID
Investigational Plan #025
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Study Sponsor
Medtronic CardioVascular, Study Director, Medtronic Cardiovascular
Verification Date
October 2021