Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Covidien

Status

Conditions: Abdominal Aortic Aneurysms

Treatments: Device: TALENT Aortic Cuff Abdominal Stent Graft

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00604643

Investigational Plan #025

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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