Aortic Aneurysm, Colon Ischemia
Conditions
Keywords
Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft
Brief 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.
Interventions
PROCEDUREReestablish 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.
Sponsors
Stanford University
University of California
Spectros Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detect colon ischemia early | Just before, and during, surgery or stenting |
Secondary
| Measure | Time frame |
|---|---|
| Allows change in the untreated course of colon ischemia | 28 days or discharge from hospital |
Countries
United States
Outcome results
None listed