Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

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.

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Key information

Conditions

Colon Ischemia Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California at Davis Medical Center, Davis, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aortic Aneurysm, intact or ruptured
Repair by catheter based stent or by open surgery during monitoring
Patent rectum
Absence of rectal bleeding

Exclusion criteria

Lack of informed consent
Rectal bleeding
Obstructed rectum

Treatment and study plan

Reestablish colon blood flow

Procedure

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.

Other names: T-Stat Ischemia Detection System (#303), T-Stat 5mm sensor catheter (#CTH-060)

Primary outcomes

Detect colon ischemia early

Time frame: Just before, and during, surgery or stenting

Secondary outcomes

Allows change in the untreated course of colon ischemia

Time frame: 28 days or discharge from hospital

Sponsors and collaborators

Lead sponsor

Spectros Corporation

Industry

Collaborators

Stanford University
University of California

Registry information

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2011
First posted: May 5, 2008
Registry last updated: Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed