Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm

Warren J. Gasper, MD

Status: Enrolling

Conditions: Paravisceral Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Device: Endovascular Branched Stent-Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT00483249

10-02810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Interventional

Experimental group

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).

Treatment:

Device: Endovascular Branched Stent-Graft