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A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures Clinical research trials and A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures. A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures
A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures
For Condition: Graft Occlusion, Vascular,Arterial Occlusive Diseases,Peripheral Vascular Diseases,Hyperplasia,Ischemia
Status: Recruiting
Sponsor(s): Corgentech ,
Synopsis: The purpose of this study is to determine the efficacy of graft pretreatment with the E2F decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of clinically significant graft stenosis (more than or equal to 70%); and on the incidence of critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).
Details: Peripheral vascular disease manifested by narrowing of the peripheral arteries is one of the more common manifestations of atherosclerotic vascular disease. Complications such as claudication, rest pain, and impaired wound healing are frequent and may result in gangrene and amputation. Restoration of circulation to the lower extremities may be undertaken using a variety of techniques including angioplasty, stenting, and bypass grafting. Approximately 99,000 infra-inguinal bypass procedures were performed in the U.S. in 1998. It is estimated that approximately 22% of all infra-inguinal bypass grafts will fail by 12 months. Graft failure rates have been estimated to increase to 40% at 12 months for patients receiving composite, cephalic or lesser saphenous (high-risk) vein grafts (Vascular Surgery Registry, Brigham and Women’s Hospital). These primary graft failures are typically due to stenoses that result from neointimal hyperplasia, a pathological adaptation process that occurs in veins exposed to the arterial circulation. The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia and poor wound healing that may result in amputation. Since the long-term patency of venous grafts can be improved with treatment prior to frank occlusion, considerable efforts have been focused on the methods for the detection of grafts at high-risk for failure. Duplex ultrasonography has been determined to be a sensitive screening test for the early detection of failing grafts. Peak systolic velocity (PSV), as measured by duplex ultrasound, has been shown to be a sensitive marker for low flow, and wave form analysis has permitted the identification of areas of stenosis in the vein under study. Management of patients who have undergone infra-inguinal bypass therefore includes routine surveillance with duplex ultrasound and the immediate correction of significant (more than or equal to 70%) graft stenoses.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PATIENTS MUST: 1) 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). 2) Be males or females of at least 18 years old. 3) Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form. 4) Have a documented negative serum pregnancy test for all women of childbearing potential. 5) 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.
Total Enrollment: 1400
Location and Contact Information:
Overall Study Official:
ToddLorenz, Study Director, Corgentech
VAMC *Recruiting*
Houston, Texas, 77030
United States
Recruiting Debbie Crawford 713-798-8968
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Richard Throm 215-707-8263
Northwestern Memorial Hospital *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Wendy Alford 312-695-2928
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Patty Nast 314-747-1761
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Ronnie Landis 212-263-7710
Peter Lougheed Centre *Recruiting*
Calgary, Alberta, T1Y6J4
Canada
Recruiting Diane Conley 403-943-4010
Vascular and Transplant Specialists, Peripheral Vascular Laboratory *Recruiting*
Norfolk, Virginia, 23510
United States
Recruiting Jan Devlin 757-466-6513
UMDNJ - New Jersey Medical School, University Hospital *Recruiting*
Newark, New Jersey,
United States
Recruiting Indu Kapadia 973-972-2408
The Surgical Group, PLLC *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Kathy Herbst 615-222-4504
Tucson Heart Hospital *Recruiting*
Tucson, Arizona, 85704
United States
Recruiting Pam Yoder 520-877-3051
Shore Memorial Hospital *Recruiting*
Nassawadox, Virginia, 23413
United States
Recruiting Cami Dolinger 757-622-2649
Tampa General Hospital *Recruiting*
Tampa, Florida, 33601
United States
Recruiting Jaime Parker 813-259-0683
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Debbie Crawford 713-798-8968
SUNY Downstate University Hospital of Brooklyn and Medical School *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Deidre McGagh 718-270-8203
Peripheral Vascular Associates *Recruiting*
San Antonio, Texas, 78215
United States
Recruiting Nancy Hill 210-225-6508
VA Palo Alto Health Care System *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Shawna Thunen 650-849-0357
Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory *Recruiting*
Chesapeake, Virginia, 23320
United States
Recruiting Cami Dolinger 757-622-2649
Chesapeake General Hospital *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Jan Devlin 757-466-6513
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting Kathleen O'Gara 212-241-5393
Kaiser Permanente - San Diego, SCPMG, Department of Surgery *Recruiting*
San Diego, California, 92120
United States
Recruiting Sonni Longson 619-528-5503
University Medical Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Jennifer Devine 520-694-6690
Vascular Specialists of Mobile, PC *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Glen Esses 251-432-0558
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Ellie Hershberger 248-551-2578
Medical College of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Amy Scott 414-384-2000
Froedert Memorial Lutheran Hospital *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Amy Scott 414-384-2000
Springhill Memorial Hopsital *Recruiting*
Mobile, Alabama, 36608
United States
Recruiting Glen Esses 251-432-0558
UMDNJ-RWJMS *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Susette Coyle 732-235-8142
Medical University of South Carolina Hospital *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Patricia Featherston 843-792-5657
Ottawa Hospital *Recruiting*
Ottawa, Ontario, KIY 4E9
Canada
Recruiting Sylvie Poloni 613-798-5555
University Hospital *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Glenda Black 205-934-7279
Southampton Memorial Hospital *Recruiting*
Franklin, Virginia, 23851
United States
Recruiting Cami Dolinger 757-622-2649
Vascular and Transplant Specialists, Peripheral Vascular Laboratory *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Cami Dolinger 757-622-2649
Tucson Vascular Surgery *Recruiting*
Tucson, Arizona, 85741
United States
Recruiting Pam Yoder 520-877-3051
The Kirklin Clinic *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Glenda Black 205-934-7279
St. Mary's Hospital *Recruiting*
Tucson, Arizona, 85745
United States
Recruiting Pam Yoder 520-877-3051
Washington Hospital Center, Center for Vascular Care *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Anne Michels 202-877-0811
Northeast Baptist Hospital *Recruiting*
San Antonio, Texas, 78217
United States
Recruiting Nancy Hill 210-225-6508
Kaiser Permanente Franklin Medical Center *Recruiting*
Denver, Colorado, 80205
United States
Recruiting Christine Neuman 303-764-5096
Emory University School of Medicine Hospital *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Carol Means 404-727-8217
Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Cathy Grier 310-652-8132
Montefiore Hospital *Recruiting*
Bronx, New York, 10467
United States
Recruiting Jaime McKay 718-920-4108
Central Arkansas Veterans Healthcare System *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Christine Harness 501-526-6447
St. Thomas Medical *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Kathy Herbst 615-222-4504
Clement J. Zablocki VAMC *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Amy Scott 414-384-2000
Virginia Vascular Associates *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Jan Devlin 757-466-6513
Baptist Health *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Christine Harness 501-526-6447
New York Presbyterian Hospital, Weill Medical College of Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Bill Blagovest 212-746-5812
Southwest Texas Methodist Hospital *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Jamie Siedel 210-828-4751
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Cheryl Maxwell 773-834-1357
Samson Showalter Vascular Specialists *Recruiting*
Sarasota, Florida, 34233
United States
Recruiting Joyce Propsom 941-917-6991
Shadyside Medical Building *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Suzanne David 412-648-2352
Robert Packer Hospital *Recruiting*
Sayre, Pennsylvania, 18840
United States
Recruiting Katherine Hoey 570-882-6070
University of Pittsburgh Medical Center, Presbyterian University Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Suzanne David 412-648-2352
Dr. Randy Shafrtiz, Clinical Office *Recruiting*
Holmdel, New Jersey, 07733
United States
Recruiting Susette Coyle 732-235-8142
Pro-Research Group *Recruiting*
San Antonio, Texas, 78224
United States
Recruiting Nancy Hill 210-225-6508
Surgical Specialists of NJ, Morris Vascular Center *Recruiting*
Morristown, New Jersey, 07960
United States
Recruiting Patty Vorel 973-971-4136
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Mary Barry 507-284-2644
Carilion Roanoke Memorial Hospital *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Bill Johnson 540-224-5967
Veterans Administration Healthcare System *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Suzanne David 412-648-2352
University of Utah Hospital and Clinics *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Melissa Hay 801-585-3663
Atlanta VA Medical Center *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Carol Means 404-727-8217
University Medical Center *Recruiting*
Lubbock, Texas, 79415
United States
Recruiting Stacey Pugh 806-743-4458
Vascular and Transplant Specialists, Peripheral Vascular Laboratory *Recruiting*
Norfolk, Virginia, 23510
United States
Recruiting Cami Dolinger 757-622-2649
Brigham & Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Fahy 617-732-4778
Vascular Institute of Georgia *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Sonya Mathewson 404-252-8377
Albany Medical Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Margaret Czerwinski 518-262-3677
Pitt County Memorial Hospital *Recruiting*
Greenville, North Carolina, 27834
United States
Recruiting Denise Brigham 252-816-9083
University of Pittsburgh Medical Centerm Shadyside Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Suzanne David 412-648-2352
Veteran's Affairs Medical Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Janet Klein 317-962-0287
Kings County Hospital *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Deidre McGagh 718-270-8203
Baptist Medical Center *Recruiting*
San Antonio, Texas, 78205
United States
Recruiting Nancy Hill 210-225-6508
Wake Forest University School of Medicine *Recruiting*
Winston Salem, North Carolina, 27157
United States
Recruiting Lorraine Harris 336-713-8847
St. Mary's Hospital *Recruiting*
Rochester, Minnesota, 55902
United States
Recruiting Mary Barry 507-284-2644
Maimonides Medical Center *Recruiting*
Brooklyn, New York, 11219
United States
Recruiting Ann Ober 718-283-7957
Dartmouth Hitchcock Medical Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting Anne Alexander 603-650-4763
Vascular & Surgery Assoc. *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Joyce Propsom 914-917-6991
St. Boniface General Hospital *Recruiting*
Winnipeg, Manitoba, R2H 2A6
Canada
Recruiting Wendy Weighell 204-235-3916
Hartford Hospital *Recruiting*
Hartford, Connecticut, 06102
United States
Recruiting Anna Hosig 860-545-1005
Saint Joseph's Hospital of Atlanta *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Sonya Mathewson 404-252-8377
Brody Module F, The Brody School of Medicine *Recruiting*
Greenville, North Carolina, 27858
United States
Recruiting Denise Brigham 252-816-9083
Southampton Memorial Hospital *Recruiting*
Franklin, Virginia, 23851
United States
Recruiting Jan Devlin 757-466-6513
Methodist Hospital *Recruiting*
Omaha, Nebraska, 68114
United States
Recruiting Lisa Kohtz 402-393-6624
Harborview Medical Center *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Patricia Cleary 206-764-2731
Beth-Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Chantel Hile 617-632-7352
Jefferson Surgical Clinic *Recruiting*
Roanoke, Virginia, 24016
United States
Recruiting Bill Johnson 540-224-5967
Shands Hospital at the University of Florida *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting Christa Hirneise 352-265-0605
Jobst Vascular Center *Recruiting*
Toledo, Ohio, 43606
United States
Recruiting Mary Corbey 419-291-2087
University of Tennessee Medical Center *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting Becky Libby 865-544-9773
Robert Wood Johnson University Hospital *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Susette Coyle 732-235-8142
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Amy McBride 215-662-6091
Gaston Memorial Hospital *Recruiting*
Gastonia, North Carolina, 28054
United States
Recruiting Jamie Christopher 704-834-2040
Texas Tech University Health Sciences Center *Recruiting*
Lubbock, Texas, 79430
United States
Recruiting Stacey Pugh 806-743-4458
The Toledo Hospital *Recruiting*
Toledo, Ohio, 43606
United States
Recruiting Mary Corbey 419-291-2087
Dept. of Surgery at Harvard Medical Faculty Physicians *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Chantel Hile 617-632-7352
Malcom Randall VA Medical Center *Recruiting*
Gainesville, Florida, 32608
United States
Recruiting Christa Hirneise 352-265-0605
Vascular and Transplant Specialists, Peripheral Vascular Laboratory *Recruiting*
Chesapeake, Virginia, 23320
United States
Recruiting Jan Devlin 757-466-6513
VA Puget Sound Health Care System *Recruiting*
Seattle, Washington, 98108
United States
Recruiting Patricia Cleary 206-764-2731
Maine Medical Center *Recruiting*
Portland, Maine, 04102
United States
Recruiting Bob Cormier 207-871-6258
Oregon Health Sciences University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Heather Kelly 503-494-7145
Exempla Healthcare Saint Joseph Hospital *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Christine Neuman 303-764-5096
Flower Hospital *Recruiting*
Sylvania, Ohio, 43560
United States
Recruiting Mary Corbey 419-291-2087
St. Paul's Hospital *Recruiting*
Saskatoon, Saskatchewan, S7M 0Z9
Canada
Recruiting Michelle Hundseth 306-241-6858
University of Maryland Hospital *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Jenelle Chen 650-320-6810
Vancouver Hospital & Health Sciences Centre *Recruiting*
Vancouver, British Columbia, V5Z 1M9
Canada
Recruiting Rebecca Fox 604-875-4065
Penn State College of Medicine *Recruiting*
Hershey, Pennsylvania, 17033
United States
Recruiting Margaret Hamm 717-531-4060
New England Medical Center Hospital *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Ann Melanson 617-636-0710
University Health Network *Recruiting*
Toronto, Ontario, M5G 2C4
Canada
Recruiting Rima Hosn 416-340-4800
Carilion Roanoke Community Hospital *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Bill Johnson 540-224-5967
University of Arkansas for Medical Sciences Hospital *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Christine Harness 501-526-6447
Northwest Hospital *Recruiting*
Tucson, Arizona, 85741
United States
Recruiting Pam Yoder 520-877-3051
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Glen Esses 251-432-0558
Shore Memorial Hospital *Recruiting*
Nassawadox, Virginia, 23413
United States
Recruiting Jan Devlin 757-466-6513
Sarasota Memorial Hospital *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Joyce Propsom 941-917-6991
Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Janet Klein 317-962-0287
Peripheral Vascular Associates *Recruiting*
San Antonio, Texas, 78217
United States
Recruiting Nancy Hill 210-225-6508
Sentara Norfolk General Hospital *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Cami Dolinger 757-622-2649
Clinical Research Center *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Joyce Propsom 941-917-6991
Johns Hopkins Hospital *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Deb Tabulov 443-287-3618
University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Kristina Cooper 585-275-5698
University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195
United States
Recruiting Patricia Cleary 206-764-2731
Department of Surgery, Division of Vascular Surgery, East Carolina University *Recruiting*
Greenville, North Carolina, 27858
United States
Recruiting Denise Brigham 252-816-9083
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Joseph DeCaro 216-445-9058
Lakeland Hospital *Recruiting*
St. Joseph, Michigan, 49085
United States
Recruiting Cheryl Maxwell 773-834-1357
Our Lady of the Lake Regional Medical Center *Recruiting*
Baton Rouge, Louisiana, 70808
United States
Recruiting Stephen Hebert 225-769-4493
Morristown Memorial Hospital *Recruiting*
Morristown, New Jersey, 07960
United States
Recruiting Patty Vorel 973-971-4136
Columbia Presbyterian Medical Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Barbara Hanley 212-305-4799
Southern Arizona Vascular Institute *Recruiting*
Tucson, Arizona, 85745
United States
Recruiting Pam Yoder 520-877-3051
London Health Sciences Centre *Recruiting*
London, Ontario, N6A 4G5
Canada
Recruiting Guy DeRose 519-667-6780
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02905
United States
Recruiting Zita Fitz-Simon 401-553-8318
Additional Information:
Study ID Numbers: CGT003-03;
Study Start Date: November 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041925
Other Peripheral Vascular Diseases Studies:
1. A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures
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A Phase III study for the prevention of autogenous vein graft failure in peripheral artery bypass procedures
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