NCT00483249

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Warren J. Gasper, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracoabdominal Aortic Aneurysm
• Paravisceral Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular Branched Stent-Graft	Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

Timeline

• Start date: 2005-05-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2007-06-06
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study