Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm

Not Applicable

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm; Paravisceral Abdominal Aortic Aneurysm

• Registration Number: NCT00483249
• Lead Sponsor: Warren J. Gasper, MD

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-06
• Status Verified: 2023-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successful implantation of TAAA branched stent-graft.	1 month

Secondary Outcome Measures

Name	Time	Method
Long term success of TAAA branched stent-graft treatment.	5 years

Trial Locations

Locations (2)

Division of Vascular Surgery, SFVAMC; 🇺🇸 San Francisco, California, United States

Division of Vascular Surgery, UCSF; 🇺🇸 San Francisco, California, United States