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Clinical Trials/NCT00583050
NCT00583050
Completed
Not Applicable

Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts

The Cleveland Clinic1 site in 1 country1,366 target enrollmentFebruary 2001

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.

Registry
clinicaltrials.gov
Start Date
February 2001
End Date
February 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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