Brief Title
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
Official Title
Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
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.
Study Type
Interventional
Primary Outcome
Freedom From Aneurysm Rupture
Condition
Thoracoabdominal Aneurysm
Intervention
Endovascular Aneurysm Repair
Study Arms / Comparison Groups
Endovascular Aneurysm Repair
Description: Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts
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
Estimated Enrollment
1366
Start Date
February 2001
Completion Date
February 1, 2020
Primary Completion Date
December 31, 2019
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Not pregnant 3. Willing and able to comply with two-year follow-up period. 4. Willing and able to give informed consent prior to enrollment 5. No known allergy to stainless steel or polyester 6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately. 7. Life expectancy greater than two years 8. High risk candidate for open surgical repair Exclusion Criteria: see above
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Behzad Farivar, M. D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00583050
Organization ID
G010002
Secondary IDs
IRB 4281
Responsible Party
Principal Investigator
Study Sponsor
The Cleveland Clinic
Collaborators
Massachusetts General Hospital
Study Sponsor
Behzad Farivar, M. D., Principal Investigator, The Cleveland Clinic
Verification Date
April 2020