Talent Aortic Cuff Stent Graft System Compassionate Use Registry
Status: | No longer available |
---|---|
Conditions: | Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2002 |
End Date: | April 2012 |
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
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.
have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for
treatment with an AneuRx Aortic Cuff.
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.
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.
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
We found this trial at
50
sites
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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