- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042081
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coronary vascular disease manifested by narrowing of the coronary arteries is one of the more common manifestations of atherosclerotic vascular disease. The clinical manifestations of coronary artery disease include death, angina pectoris, myocardial infarction, congestive heart failure and arrhythmia. Restoration of circulation to the heart may be undertaken using a variety of techniques including angioplasty, stenting, and bypass grafting.
Approximately 359,000 patients underwent coronary bypass procedures in the U.S. in 1999. Long term studies have observed an incidence of vein graft occlusion at 19% at 1 year, 25% at 5 years and 50% by 15 years after operation for an overall rate of 2.5% per year after the first year of observation. The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia, myocardial infarction and death.
CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein graft failure. It acts by inhibiting the transcription factor, E2F, which is activated in response to injury such as that which occurs when thin-walled vein grafts are exposed to the pressures of the arterial circulation. Blockade of E2F inhibits smooth muscle cell proliferation and redirects the vein graft remodeling that occurs within the first several days after implantation towards medial hypertrophy and strengthening of the medial layer and blunts formation of neointima. Inhibition of neotinimal formation coupled with expansion of the media should result in a decreased risk of the accelerated atherosclerosis and consequent vein graft failure over several years.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35209
- Brookwood Medical Center
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Birmingham, Alabama, United States, 35235
- Cardio-Thoracic Surgeons, P.C.
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Birmingham, Alabama, United States, 35235
- Medical Center East
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Birmingham, Alabama, United States, 35209
- Cardio-Thoracic Surgeons, P.C.
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Birmingham, Alabama, United States, 35213
- Baptist Medical Center - Montclair
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Birmingham, Alabama, United States, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Daly City, California, United States, 94015
- Seton Medical Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Palm Springs, California, United States, 92262
- Desert Regional Medical Center
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Stockton, California, United States, 95204
- St. Joseph's Medical Center
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- St. Vincent's Medical Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Florida
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Atlantis, Florida, United States, 33462
- JFK Medical Center
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Atlantis, Florida, United States, 33462
- Florida Cardiovascular Research
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Clearwater, Florida, United States, 33756
- Morton Plant Hospital
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Melbourne, Florida, United States, 32901
- Holmes Regional Medical Center
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Orlando, Florida, United States, 32803
- Florida Hospital
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Orlando, Florida, United States, 32806
- Orlando Heart Center
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Orlando, Florida, United States, 32801
- Cardiovascular Surgeons, P.A.
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Orlando, Florida, United States, 32806
- Orlando Cardiovascular Center, LLLP
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Orlando, Florida, United States, 32806
- Orlando Regional Med Center
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Orlando, Florida, United States, 32819
- Orlando Heart Center/Sand Lake
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Sarasota, Florida, United States, 34239
- Clinical Research Center
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Health Care System
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30308
- Crawford Long Hospital
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Illinois
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Belleville, Illinois, United States, 62220
- St. Elizabeth's Hospital
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Belleville, Illinois, United States, 62226
- Memorial Hospital
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, United States, 60631
- Resurrection Medical Center
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Chicago, Illinois, United States, 60612
- Rush Presbyterian St. Luke's Medical Center
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Chicago, Illinois, United States, 60611
- Northwestern Medical Facility Foundation
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Chicago, Illinois, United States, 60612
- Rush Professional Building
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Healthcare
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Evanston, Illinois, United States, 60202
- St. Francis Hospital of Evanston
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Healthcare, Highland Park Hospital
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Maywood, Illinois, United States, 60153
- Loyola University Chicago Medical Center
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Naperville, Illinois, United States, 60540
- Edward Hospital & Health Services
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Oak Lawn, Illinois, United States, 60453
- Advocate Christ Hospital and Medical Center
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Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
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Springfield, Illinois, United States, 62702
- Memorial Medical Center
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Springfield, Illinois, United States, 62702
- St. John's Hospital
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
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Winfield, Illinois, United States, 60190
- Central DuPage Hospital
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Indiana
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Indianapolis, Indiana, United States, 46290
- The Heart Center of Indiana
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Indianapolis, Indiana, United States, 46260
- St. Vincent Hospital and Health Care Service
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Iowa
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Davenport, Iowa, United States, 52803
- Genesis Medical Center
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Davenport, Iowa, United States, 52803
- Genesis Heart Institute
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Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Overland Park, Kansas, United States, 66204
- Georgetown Professional Plaza
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Shawnee Mission, Kansas, United States, 66204
- Shawnee Mission Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40202
- Jewish Hospital Health Care Services
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, United States, 21215
- Cardiac Surgery Associates
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Salisbury, Maryland, United States, 21801
- Peninsula Regional Medical Center
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Takoma Park, Maryland, United States, 20912
- Washington Adventist Hospital
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Towson, Maryland, United States, 21204
- St. Joseph Medical Center
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Towson, Maryland, United States, 21204
- Cardiac Surgery Associates
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Towson, Maryland, United States, 21204
- Midatlantic Cardiovascular Associates, P.A.
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Michigan
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Flint, Michigan, United States, 48532
- McLaren Regional Medical Center
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health Hospitals
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Lansing, Michigan, United States, 48910
- Ingham Regional Medical Center
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Lansing, Michigan, United States, 48910
- Thoracic & Cardiovascular Healthcare Foundation
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Lansing, Michigan, United States, 48910
- Thoracic & Cardiovascular Institute
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Petoskey, Michigan, United States, 49770
- Northern Michigan Hospital
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Petoskey, Michigan, United States, 49770
- Cardiology Consultants, PC
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Petoskey, Michigan, United States, 49770
- Great Lakes Cardiothoracic and Vascular Surgery
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Petoskey, Michigan, United States, 49770
- Petoskey Cardiology
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Saginaw, Michigan, United States, 48601
- Michigan Cardiovascular Institute
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Saginaw, Michigan, United States, 48602
- Convenant Medical Center
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Minnesota
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Duluth, Minnesota, United States, 55805
- St. Mary's/Duluth Clinic Health System
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States, 55416
- Park Nicollet Institute
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St. Louis Park, Minnesota, United States, 55426
- Park Nicollet Heart Center
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St. Louis Park, Minnesota, United States, 55426
- Methodist Hospital
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
- Forrest General Hospital
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Missouri
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Joplin, Missouri, United States, 64804
- St. John's Regional Medical Center
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Kansas City, Missouri, United States, 64114
- 930 Carondelet Drive
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St. Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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Omaha, Nebraska, United States, 68131
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 68131
- Nebraska Heart Institute
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Papillion, Nebraska, United States, 68046
- Nebraska Heart Institute
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New Jersey
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Morristown, New Jersey, United States, 07962
- Morristown Memorial Hospital
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New Brunswick, New Jersey, United States, 08903
- Robert Wood Johnson University Hospital
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New Brunswick, New Jersey, United States, 08903
- Umdnj-Rwjms
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Ridgewood, New Jersey, United States, 07450
- The Valley Hospital
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New York
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New York, New York, United States, 10021
- Lenox Hill Hospital
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New York, New York, United States, 10032
- New York Presbyterian Medical Center, Milstein Hospital Building
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Valhalla, New York, United States, 10595
- Westchester Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27154
- University of North Carolina Hospitals
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Chapel Hill, North Carolina, United States, 27514
- Ambulatory Care Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Gastonia, North Carolina, United States, 28054
- Gaston Memorial Hospital
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Greenville, North Carolina, United States, 27834
- Pitt County Memorial Hospital
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Greenville, North Carolina, United States, 27858
- Brody School of Medicine, East Carolina University
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Pinehurst, North Carolina, United States, 28374
- FirstHealth Moore Regional Hospital
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Winston Salem, North Carolina, United States, 27103
- Walley, Morgan & Duncan, M.D., P.A.
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Winston-Salem, North Carolina, United States, 27103
- Forysyth Medical Center
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North Dakota
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Fargo, North Dakota, United States, 58122
- MeritCare Medical Group
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Fargo, North Dakota, United States, 58122
- MeritCare Clinic at MeritCare Hospital
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Ohio
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Akron, Ohio, United States, 44307
- Akron General Medical Center
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Canton, Ohio, United States, 44710
- Aultman Health Foundation
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Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital
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Cincinnati, Ohio, United States, 45220
- Cardiovascular & Thoracic Surgeons
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Cincinnati, Ohio, United States, 45242
- Cardiovascular & Thoracic Surgeons, Inc.
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Kettering, Ohio, United States, 45429
- Kettering Medical Center Network, Kettering Hospital
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Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital
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Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Presbyterian Hospital, University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center, Presbyterian Hospital
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Sayre, Pennsylvania, United States, 18840
- Robert Packer Hospital
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Sayre, Pennsylvania, United States, 18840
- Guthrie Clinic
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West Chester, Pennsylvania, United States, 19380
- The Chester County Hospital
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Hospital
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Hospital System
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Greenville, South Carolina, United States, 29605
- Upstate Cardiothoracic Surgery, Greenville Hospital System
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Tennessee
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Memphis, Tennessee, United States, 38119
- Saint Francis Hospital
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Texas
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Austin, Texas, United States, 78756
- Heart Hospital of Austin
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Dallas, Texas, United States, 75231
- Presbyterian Hospital of Dallas
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Dallas, Texas, United States, 75235
- St. Paul University Hospital
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Denton, Texas, United States, 76210
- Denton Regional Medical Center
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Plano, Texas, United States, 75075
- Medical Center Plano
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San Antonio, Texas, United States, 78229
- Southwest Texas Methodist Hospital
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San Antonio, Texas, United States, 78233
- Northeast Methodist Hospital
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah Health Sciences Center
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Virginia
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Lynchburg, Virginia, United States, 24501
- Lynchburg General Hospital
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Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Hospital
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Norfolk, Virginia, United States, 23510
- Mid-Atlantic Cardiothoracic Surgeons, Ltd.
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Washington
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Bellingham, Washington, United States, 98225
- St. Joseph Hospital
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Spokane, Washington, United States, 99204
- Deaconess Medical Center
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Spokane, Washington, United States, 99204
- Northwest Heart and Lung Surgical Associates
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West Virginia
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Charleston, West Virginia, United States, 25304
- Charleston Area Medical Center
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Charleston, West Virginia, United States, 25304
- CAMC Health Education and Research Institute, Clinical Trials Center
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Wisconsin
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Appleton, Wisconsin, United States, 54911
- Appleton Heart Institute at Appleton Medical Center
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Milwaukee, Wisconsin, United States, 53215
- St. Luke's Medical Center
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Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital
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Wausau, Wisconsin, United States, 54401
- Wausau Heart and Lung Surgeons
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Wausau, Wisconsin, United States, 54401
- Community Health Care/Wausau Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PATIENTS MUST:
- Have coronary artery disease and be scheduled to undergo a coronary artery bypass (CABG) procedure that is to include at least two segments of autogenous vein (sequential grafts do not count as two separate grafts).
- Be between 18 and 80 years old.
- 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.
- Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.
- (If one of the first 2400 patients enrolled) have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form for the Angiography population.
- Note: Patients who are to receive an arterial bypass to the left anterior descending artery in addition to the two vein grafts required by the protocol ARE eligible for this study.
- Note: Patients ARE eligible for enrollment regardless of whether the planned procedure is to be on or off cardiopulmonary bypass pump.
- Note: Patients who do not wish to undergo elective Angiography at one year SHOULD NOT be enrolled in the first 2400 patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Todd Lorenz, M.D., Anesiva, Inc.
Publications and helpful links
General Publications
- Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.
- Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.
- Hess CN, Lopes RD, Gibson CM, Hager R, Wojdyla DM, Englum BR, Mack MJ, Califf RM, Kouchoukos NT, Peterson ED, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: insights from PREVENT IV. Circulation. 2014 Oct 21;130(17):1445-51. doi: 10.1161/CIRCULATIONAHA.113.008193. Epub 2014 Sep 26.
- Harskamp RE, Alexander JH, Schulte PJ, Brophy CM, Mack MJ, Peterson ED, Williams JB, Gibson CM, Califf RM, Kouchoukos NT, Harrington RA, Ferguson TB Jr, Lopes RD. Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial. JAMA Surg. 2014 Aug;149(8):798-805. doi: 10.1001/jamasurg.2014.87. Erratum In: JAMA Surg. 2014 Sep;149(9):961.
- Lopes RD, Williams JB, Mehta RH, Reyes EM, Hafley GE, Allen KB, Mack MJ, Peterson ED, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB, Lorenz TJ, Alexander JH. Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results. Am Heart J. 2012 Sep;164(3):379-386.e1. doi: 10.1016/j.ahj.2012.05.019.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGT003-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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