Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm

Not Applicable

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm; Paravisceral Abdominal Aortic Aneurysm
• Interventions: Device: Endovascular Branched Stent-Graft

• 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

Arm && Interventions

Group	Intervention	Description
Interventional	Endovascular Branched Stent-Graft	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).

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