Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracoabdominal Aneurysm
- Sponsor
- The Cleveland Clinic
- Enrollment
- 1366
- Locations
- 1
- Primary Endpoint
- Freedom From Aneurysm Rupture
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
Detailed Description
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.
Investigators
Behzad Farivar, M. D.
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age.
- •Not pregnant
- •Willing and able to comply with two-year follow-up period.
- •Willing and able to give informed consent prior to enrollment
- •No known allergy to stainless steel or polyester
- •No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
- •Life expectancy greater than two years
- •High risk candidate for open surgical repair
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Freedom From Aneurysm Rupture
Time Frame: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan