Status:
COMPLETED
Endothelial Function and Vein Graft Remodeling
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Peripheral Arterial Disease
Cardiovascular Disease
Eligibility:
All Genders
22-89 years
Brief 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 narrow...
Detailed Description
Despite the acceptance of catheter-based approaches to lower extremity reconstruction, bypass with autogenous vein remains the most durable option. In the United States alone there are approximately 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 16 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00831090
Start Date
January 1 2009
End Date
January 16 2015
Last Update
September 23 2022
Active Locations (2)
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1
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
2
University of California, San Francisco
San Francisco, California, United States, 94143