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Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

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Disease Information

Descriptive Information
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Freedom from Aneurysm Rupture
Secondary Outcome Measure †
Condition † Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm
Intervention † DeviceEndovascular Aneurysm Repair
Study Arms / Comparison Groups Endovascular Aneurysm Repair 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 † 1340
Start Date † February 2001
Completion Date December 2020
Primary Completion Date December 2020
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 †† Yuki Kuramochi, RN, BSN, 216-445-4063, kuramoy@ccf.org
Location Countries † United States
Administrative Information
NCT ID † NCT00583050
Organization ID G010002
Secondary IDs †† IRB 4281
Responsible Party Sponsor-Investigator
Study Sponsor † Matthew Eagleton
Collaborators †† The Cleveland Clinic
Investigators † Principal Investigator: Matthew J Eagleton, MD, The Cleveland Clinic
Information Provided By
Verification Date April 2017
First Received Date † December 20, 2007
Last Updated Date April 12, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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