NCT00671203

Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Spectros Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable. This purpose of this study is to establish how T-Stat can best be used to prevent deaths.

Conditions

• Colon Ischemia
• Aortic Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Reestablish colon blood flow	If ischemia is detected, and the detection in consistent with the physician's clinical view, blood flow to the colon is established using any of the known techniques that would be used had the diagnosis been made in the absence of T-Stat, which include changes in the deployment of stents and/or coils, reanastomosis, reimplantation, or stenting, of obstructed vessels, or other established techniques.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-09-01
• Completion: 2011-01-01
• First posted: 2008-05-05
• Last updated: 2011-02-01

Locations

2 sites across 1 country: United States