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
1 other identifier
interventional
3,000
1 country
154
Brief Summary
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Jul 2002
154 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 22, 2002
CompletedFirst Posted
Study publicly available on registry
July 24, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedMay 5, 2006
July 1, 2005
July 22, 2002
May 4, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Anesiva, Inc.lead
Study Sites (154)
Brookwood Medical Center
Birmingham, Alabama, 35209, United States
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35209, United States
Baptist Medical Center - Montclair
Birmingham, Alabama, 35213, United States
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35213, United States
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35235, United States
Medical Center East
Birmingham, Alabama, 35235, United States
Seton Medical Center
Daly City, California, 94015, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
St. Joseph's Medical Center
Stockton, California, 95204, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Florida Cardiovascular Research
Atlantis, Florida, 33462, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Cardiovascular Surgeons, P.A.
Orlando, Florida, 32801, United States
Florida Hospital
Orlando, Florida, 32803, United States
Orlando Cardiovascular Center, LLLP
Orlando, Florida, 32806, United States
Orlando Heart Center
Orlando, Florida, 32806, United States
Orlando Regional Med Center
Orlando, Florida, 32806, United States
Orlando Heart Center/Sand Lake
Orlando, Florida, 32819, United States
Clinical Research Center
Sarasota, Florida, 34239, United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239, United States
Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
St. Elizabeth's Hospital
Belleville, Illinois, 62220, United States
Memorial Hospital
Belleville, Illinois, 62226, United States
Northwestern Medical Facility Foundation
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Rush Professional Building
Chicago, Illinois, 60612, United States
Resurrection Medical Center
Chicago, Illinois, 60631, United States
Evanston Northwestern Healthcare, Highland Park Hospital
Evanston, Illinois, 60201, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
St. Francis Hospital of Evanston
Evanston, Illinois, 60202, United States
Loyola University Chicago Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital & Health Services
Naperville, Illinois, 60540, United States
Advocate Christ Hospital and Medical Center
Oak Lawn, Illinois, 60453, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
Springfield, Illinois, 62702, United States
St. John's Hospital
Springfield, Illinois, 62702, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
St. Vincent Hospital and Health Care Service
Indianapolis, Indiana, 46260, United States
The Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Genesis Heart Institute
Davenport, Iowa, 52803, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Georgetown Professional Plaza
Overland Park, Kansas, 66204, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Jewish Hospital Health Care Services
Louisville, Kentucky, 40202, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Cardiac Surgery Associates
Baltimore, Maryland, 21215, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Cardiac Surgery Associates
Towson, Maryland, 21204, United States
Midatlantic Cardiovascular Associates, P.A.
Towson, Maryland, 21204, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
McLaren Regional Medical Center
Flint, Michigan, 48532, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Ingham Regional Medical Center
Lansing, Michigan, 48910, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910, United States
Thoracic & Cardiovascular Institute
Lansing, Michigan, 48910, United States
Cardiology Consultants, PC
Petoskey, Michigan, 49770, United States
Great Lakes Cardiothoracic and Vascular Surgery
Petoskey, Michigan, 49770, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Petoskey Cardiology
Petoskey, Michigan, 49770, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601, United States
Convenant Medical Center
Saginaw, Michigan, 48602, United States
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Park Nicollet Institute
Minneapolis, Minnesota, 55416, United States
Methodist Hospital
Saint Louis Park, Minnesota, 55426, United States
Park Nicollet Heart Center
Saint Louis Park, Minnesota, 55426, United States
Forrest General Hospital
Hattiesburg, Mississippi, 39401, United States
St. John's Regional Medical Center
Joplin, Missouri, 64804, United States
930 Carondelet Drive
Kansas City, Missouri, 64114, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Nebraska Heart Institute
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68131, United States
Nebraska Heart Institute
Papillion, Nebraska, 68046, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Umdnj-Rwjms
New Brunswick, New Jersey, 08903, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Lenox Hill Hospital
New York, New York, 10021, United States
New York Presbyterian Medical Center, Milstein Hospital Building
New York, New York, 10032, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27154, United States
Ambulatory Care Center
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27834, United States
Brody School of Medicine, East Carolina University
Greenville, North Carolina, 27858, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Forysyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Walley, Morgan & Duncan, M.D., P.A.
Winston-Salem, North Carolina, 27103, United States
MeritCare Clinic at MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Medical Group
Fargo, North Dakota, 58122, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Cardiovascular & Thoracic Surgeons
Cincinnati, Ohio, 45220, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Cardiovascular & Thoracic Surgeons, Inc.
Cincinnati, Ohio, 45242, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Kettering Medical Center Network, Kettering Hospital
Kettering, Ohio, 45429, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Presbyterian Hospital, University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center, Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
The Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Upstate Cardiothoracic Surgery, Greenville Hospital System
Greenville, South Carolina, 29605, United States
Saint Francis Hospital
Memphis, Tennessee, 38119, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
St. Paul University Hospital
Dallas, Texas, 75235, United States
Denton Regional Medical Center
Denton, Texas, 76210, United States
Medical Center Plano
Plano, Texas, 75075, United States
Southwest Texas Methodist Hospital
San Antonio, Texas, 78229, United States
Northeast Methodist Hospital
San Antonio, Texas, 78233, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Lynchburg General Hospital
Lynchburg, Virginia, 24501, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Mid-Atlantic Cardiothoracic Surgeons, Ltd.
Norfolk, Virginia, 23510, United States
St. Joseph Hospital
Bellingham, Washington, 98225, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
Northwest Heart and Lung Surgical Associates
Spokane, Washington, 99204, United States
CAMC Health Education and Research Institute, Clinical Trials Center
Charleston, West Virginia, 25304, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Appleton Heart Institute at Appleton Medical Center
Appleton, Wisconsin, 54911, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Community Health Care/Wausau Hospital
Wausau, Wisconsin, 54401, United States
Wausau Heart and Lung Surgeons
Wausau, Wisconsin, 54401, United States
Related Publications (5)
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.
PMID: 16287955RESULTHarskamp 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.
PMID: 26647082DERIVEDHess 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.
PMID: 25261549DERIVEDHarskamp 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.
PMID: 25073921DERIVEDLopes 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.
PMID: 22980305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Todd Lorenz, M.D.
Anesiva, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2002
First Posted
July 24, 2002
Study Start
July 1, 2002
Study Completion
February 1, 2005
Last Updated
May 5, 2006
Record last verified: 2005-07