Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

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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 Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Official Title

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Brief Summary

      This is a study to assess the safety and effectiveness of endovascular treatment of
      thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The
      investigational operation involves placing a stent-graft over the aortic aneurysm.

Detailed Description

      A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and
      abdomen. The standard operation for TAAA of PVAAA is performed through a long incision
      extending down the side of the chest and the front of the abdomen. In the standard operation,
      the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational
      operation is done making small incisions in both groins and the right arm and placing a graft
      in the aorta through tubes that are inserted through the femoral and brachial arteries, than
      fastening it in position with metal springs(stents). The combination of a stent and a graft
      is known as a stent-graft. Compared with standard operation, the potential advantages of
      endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a
      lower risk of pulmonary or cardiac complications and shorter hospital stay. The main
      disadvantage of endovascular TAAA/PVAAA is an unknown success rate.

Study Type

Interventional

Primary Outcome

Successful implantation of TAAA branched stent-graft.

Secondary Outcome

 Long term success of TAAA branched stent-graft treatment.

Condition

Thoracoabdominal Aortic Aneurysm

Intervention

Endovascular Branched Stent-Graft

Study Arms / Comparison Groups

 Interventional
Description:  Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).

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

250

Start Date

May 2005

Completion Date

June 2022

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria

          1. Aortic aneurysms:

               -  greater than or equal to 6 cm in diameter in men,

               -  greater than or equal to 5.5 cm in diameter in women,

               -  and/or larger than 5 cm in diameter and enlarging at a rate of more than 5
                  mm/year,

               -  and/or iliac aneurysms larger than 4 cm in diameter.

          2. Anticipated mortality comparable to published rates with conventional surgical
             treatment.

          3. Life expectancy more than 2 years.

          4. Ability to give informed consent.

          5. Willingness to comply with follow-up schedule.

          6. Suitable arterial anatomy for endovascular repair.

        Exclusion Criteria

          1. Free rupture of the aneurysm.

          2. Pregnancy.

          3. Known allergy to Nitinol, stainless steel, or polyester.

          4. Unwillingness or inability to comply with the follow up schedule.

          5. Serious systemic or groin infection.

          6. Uncorrectable coagulopathy.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Linda M Reilly, MD, 415 353 4366, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00483249

Organization ID

10-02810

Responsible Party

Sponsor-Investigator

Study Sponsor

Timothy Chuter, MD

Study Sponsor

Linda M Reilly, MD, Principal Investigator, University of California, San Francisco

Verification Date

July 2020