Endothelial Function and Vein Graft Remodeling

Official Title:

Endothelial Function and Vein Graft Remodeling

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Observational 22 - 89 Years University of California, San Francisco 10-02338
HL 92163-01
NCT00831090
Ongoing but not enrolling patients

Study Design:


Principal Investigator

Assistant Professor of Clinical Surgery
Division of Vascular and Endovascular Surgery
Acting Chief, Section of Vascular Surgery,
San Francisco VA Medical Center
Director, Vascular Integrated Physiology and
Experimental Therapeutics (ViperX)

Clinical Research Coordinator

San Francisco VA Medical Center
(415) 221-4810 Ext. 2-4708 Phone
(415) 379-5534 Fax

Trial Summary

The purpose of this study is to better understand why some vein bypass grafts develop narrowing. Evidence suggests that there is a relationship between inflammatory markers in the blood and the narrowing that occurs in blood vessels. In this study, we will look at inflammatory markers in the blood and how well the vein graft functions.

Eligibility

Inclusion Criteria:
  • Age > 22 or < 90 years
  • Undergoing lower extremity (infrainguinal) bypass using autologous vein for the
    treatment of disabling claudication or critical limb ischemia secondary to chronic
    atherosclerotic occlusive disease
  • Able to understand, give, and take part in the consent process
Exclusion Criteria:
  • Age < 22 or > 90 years
  • Grafts employing prosthetic or other non-autologous vein material in any part (e.g.
    composite grafts). [Patch angioplasty of inflow and outflow vessel permissible with
    any material]
  • Vasculitis, trauma, acute embolic disease as etiology of limb ischemia
  • History of diagnosed hypercoagulable state
  • Evidence of active infection - pneumonia, urinary tract, etc., requiring medical
    therapy
  • Evidence of significant local sepsis in foot or limb prior to bypass
  • Patients taking immunosuppressant medications (steroids, chemotherapeutic agents)
  • Other concurrent significant illness within 30 days
  • Non-English speakers

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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