Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Primary Purpose
Colon Ischemia, Aortic Aneurysm
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reestablish colon blood flow
Sponsored by
About this trial
This is an interventional treatment trial for Colon Ischemia focused on measuring Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft
Eligibility Criteria
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
Sites / Locations
- University of California at Davis Medical Center
- Stanford University Vascular Surgery
Outcomes
Primary Outcome Measures
Detect colon ischemia early
Secondary Outcome Measures
Allows change in the untreated course of colon ischemia
Full Information
NCT ID
NCT00671203
First Posted
May 1, 2008
Last Updated
January 30, 2011
Sponsor
Spectros Corporation
Collaborators
Stanford University, University of California
1. Study Identification
Unique Protocol Identification Number
NCT00671203
Brief Title
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Official Title
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Spectros Corporation
Collaborators
Stanford University, University of California
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Ischemia, Aortic Aneurysm
Keywords
Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Reestablish colon blood flow
Other Intervention Name(s)
T-Stat Ischemia Detection System (#303), T-Stat 5mm sensor catheter (#CTH-060)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detect colon ischemia early
Time Frame
Just before, and during, surgery or stenting
Secondary Outcome Measure Information:
Title
Allows change in the untreated course of colon ischemia
Time Frame
28 days or discharge from hospital
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California at Davis Medical Center
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University Vascular Surgery
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17137857
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. doi: 10.1016/j.gie.2006.05.007. Epub 2006 Sep 20.
Results Reference
background
PubMed Identifier
15166566
Citation
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. doi: 10.1097/00000542-200406000-00019.
Results Reference
background
PubMed Identifier
16978651
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. doi: 10.1016/j.jss.2006.05.014. Epub 2006 Sep 15.
Results Reference
result
PubMed Identifier
18295116
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.
Results Reference
result
Links:
URL
http://www.spectros.com
Description
Spectros Corporation T-Stat Web Site
Learn more about this trial
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
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