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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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