Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Aortic Aneurysm Clinical Trial

Official title:

Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671203
• Other study ID #: AAA-002
• Secondary ID: NIH DK068927
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2008
• Last updated: January 30, 2011
• Start date: June 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Spectros Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Colon Ischemia
• Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	University of California at Davis Medical Center	Davis	California
United States	Stanford University Vascular Surgery	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Spectros Corporation	Stanford University, University of California

Country where clinical trial is conducted

United States, 

References & Publications (4)

Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. — View Citation

Friedland S, Benaron D, Coogan S, Sze DY, Soetikno R. Diagnosis of chronic mesenteric ischemia by visible light spectroscopy during endoscopy. Gastrointest Endosc. 2007 Feb;65(2):294-300. Epub 2006 Sep 20. — View Citation

Lee ES, Bass A, Arko FR, Heikkinen M, Harris EJ, Zarins CK, van der Starre P, Olcott C. Intraoperative colon mucosal oxygen saturation during aortic surgery. J Surg Res. 2006 Nov;136(1):19-24. Epub 2006 Sep 15. — View Citation

Lee ES, Pevec WC, Link DP, Dawson DL. Use of T-Stat to predict colonic ischemia during and after endovascular aneurysm repair: a case report. J Vasc Surg. 2008 Mar;47(3):632-4. doi: 10.1016/j.jvs.2007.09.037. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect colon ischemia early		Just before, and during, surgery or stenting
Secondary	Allows change in the untreated course of colon ischemia		28 days or discharge from hospital

External Links

•   Spectros Corporation T-Stat Web Site