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Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

This study has been completed.
Sponsor:
Collaborators:
Stanford University
University of California
Information provided by:
Spectros Corporation
ClinicalTrials.gov Identifier:
NCT00671203
First received: May 1, 2008
Last updated: January 30, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Colon Ischemia
Aortic Aneurysm
 Procedure: Reestablish colon blood flow
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spectros Corporation:

Primary Outcome Measures:
  • Detect colon ischemia early [ Time Frame: Just before, and during, surgery or stenting ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Allows change in the untreated course of colon ischemia [ Time Frame: 28 days or discharge from hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: June 2007
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • T-Stat Ischemia Detection System (#303)
    • T-Stat 5mm sensor catheter (#CTH-060)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671203

Locations
United States, California
University of California at Davis Medical Center
Davis, California, United States, 95817
Stanford University Vascular Surgery
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Spectros Corporation
Stanford University
University of California
  More Information

Additional Information:
Spectros Corporation T-Stat Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Spectros Corporation, Clinical Studies Director
ClinicalTrials.gov Identifier: NCT00671203     History of Changes
Other Study ID Numbers: AAA-002, NIH DK068927
Study First Received: May 1, 2008
Last Updated: January 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectros Corporation:
Tissue oximetry
Ischemia
Aortic Aneurysm Repair
Aortic Stent
 Vascular Stent
Aortic graft
Vascular graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Ischemia
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pathologic Processes
Erythromycin
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013