Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
Not Applicable
Completed
- Conditions
- Thoracoabdominal AneurysmAbdominal Aortic Aneurysm
- Registration Number
- NCT00583050
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1366
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
see above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Freedom From Aneurysm Rupture 2 years Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic🇺🇸Cleveland, Ohio, United States