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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

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