Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures
Peripheral Vascular Diseases, Arterial Occlusive Diseases, Ischemia
About this trial
This is an interventional prevention trial for Peripheral Vascular Diseases focused on measuring atherosclerotic vascular disease, chronic critical limb ischemia, neointimal hyperplasia, peripheral vein bypass, infra-inguinal bypass grafting surgery, graft stenosis, occluded grafts
Eligibility Criteria
PATIENTS MUST: Be scheduled to undergo infra-inguinal bypass grafting surgery using excised autogenous vein for Chronic Critical Limb Ischemia (i.e., rest pain, non-healing ulceration or gangrene). For patients presenting with rest pain as the only manifestation of CCLI, must have the diagnosis confirmed by at least one of the following,: i.) an ankle pressure of < 50 mmHg (or ABI <0.4), ii.) a toe pressure < 30 mmHg, iii.) a reduced TCPO2 < 30 mmHg, or iv.) a severely ischemic or flat line transtarsal pulse volume recording (i.e., Category V). Be males or females of at least 18 years old. Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form. Have a documented negative serum pregnancy test for all women of childbearing potential. Be using an acceptable method of birth control if of reproductive potential. Note: Patients undergoing operations to replace previously occluded grafts that involve placement of an entirely new bypass graft ARE eligible for this study.
Sites / Locations
- The Kirklin Clinic
- University Hospital
- Mobile Infirmary Medical Center
- Vascular Specialists of Mobile, PC
- Springhill Memorial Hopsital
- Tucson Heart Hospital
- University Medical Center
- Northwest Hospital
- Tucson Vascular Surgery
- Southern Arizona Vascular Institute
- St. Mary's Hospital
- Baptist Health
- Central Arkansas Veterans Healthcare System
- University of Arkansas for Medical Sciences Hospital
- Cedars-Sinai Medical Center
- VA Palo Alto Health Care System
- Kaiser Permanente - San Diego, SCPMG, Department of Surgery
- Kaiser Permanente Franklin Medical Center
- Exempla Healthcare Saint Joseph Hospital
- Hartford Hospital
- Washington Hospital Center, Center for Vascular Care
- Malcom Randall VA Medical Center
- Shands Hospital at the University of Florida
- Samson Showalter Vascular Specialists
- Clinical Research Center
- Sarasota Memorial Hospital
- Vascular & Surgery Assoc.
- Tampa General Hospital
- Emory University School of Medicine Hospital
- Saint Joseph's Hospital of Atlanta
- Vascular Institute of Georgia
- Atlanta VA Medical Center
- Northwestern Memorial Hospital
- University of Chicago
- Methodist Hospital
- Veteran's Affairs Medical Center
- Our Lady of the Lake Regional Medical Center
- Maine Medical Center
- University of Maryland Hospital
- Johns Hopkins Hospital
- New England Medical Center Hospital
- Brigham & Women's Hospital
- Beth-Israel Deaconess Medical Center
- Dept. of Surgery at Harvard Medical Faculty Physicians
- William Beaumont Hospital
- O.W. Brown, M.D.
- Lakeland Hospital
- Steven D. Rimar, M.D.
- St. Mary's Hospital
- Mayo Clinic
- Washington University School of Medicine
- Methodist Hospital
- Dartmouth Hitchcock Medical Center
- Dr. Randy Shafrtiz, Clinical Office
- Morristown Memorial Hospital
- Surgical Specialists of NJ, Morris Vascular Center
- Robert Wood Johnson University Hospital
- Umdnj-Rwjms
- UMDNJ - New Jersey Medical School, University Hospital
- Albany Medical Center
- Montefiore Hospital
- Kings County Hospital
- SUNY Downstate University Hospital of Brooklyn and Medical School
- Maimonides Medical Center
- New York Presbyterian Hospital, Weill Medical College of Cornell University
- Mount Sinai Medical Center
- Columbia Presbyterian Medical Center
- University of Rochester Medical Center
- Gaston Memorial Hospital
- Pitt County Memorial Hospital
- Department of Surgery, Division of Vascular Surgery, East Carolina University
- Wake Forest University School of Medicine
- Cleveland Clinic Foundation
- Flower Hospital
- Jobst Vascular Center
- The Toledo Hospital
- Oregon Health Sciences University
- Penn State College of Medicine
- Hospital of the University of Pennsylvania
- Temple University Hospital
- Veterans Administration Healthcare System
- Robert Packer Hospital
- Rhode Island Hospital
- Medical University of South Carolina Hospital
- University of Tennessee Medical Center
- St. Thomas Medical
- The Surgical Group, PLLC
- Baylor College of Medicine
- VAMC
- University Medical Center
- Texas Tech University Health Sciences Center
- Baptist Medical Center
- Peripheral Vascular Associates
- Northeast Baptist Hospital
- Peripheral Vascular Associates
- Pro-Research Group
- Southwest Texas Methodist Hospital
- University of Utah Hospital and Clinics
- Vascular and Transplant Specialists, Peripheral Vascular Laboratory
- Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory
- Southampton Memorial Hospital
- Shore Memorial Hospital
- Chesapeake General Hospital
- Vascular and Transplant Specialists, Peripheral Vascular Laboratory
- Virginia Vascular Associates
- Sentara Norfolk General Hospital
- Vascular and Transplant Specialists, Peripheral Vascular Laboratory
- Carilion Roanoke Community Hospital
- Carilion Roanoke Memorial Hospital
- Jefferson Surgical Clinic
- Harborview Medical Center
- VA Puget Sound Health Care System
- University of Washington Medical Center
- Froedert Memorial Lutheran Hospital
- Medical College of Wisconsin
- Clement J. Zablocki VAMC
- Peter Lougheed Centre
- Vancouver Hospital & Health Sciences Centre
- St. Boniface General Hospital
- London Health Sciences Centre
- Ottawa Hospital
- University Health Network
- St. Paul's Hospital