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Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CGT003 (E2F Duplex Decoy)
Sponsored by
Anesiva, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring CABG, coronary artery bypass surgery, coronary artery disease, coronary arteriosclerosis, coronary stenosis, coronary occlusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brookwood Medical Center
  • Cardio-Thoracic Surgeons, P.C.
  • Baptist Medical Center - Montclair
  • Cardio-Thoracic Surgeons, P.C.
  • Cardio-Thoracic Surgeons, P.C.
  • Medical Center East
  • Seton Medical Center
  • Cedars-Sinai Medical Center
  • Desert Regional Medical Center
  • St. Joseph's Medical Center
  • St. Vincent's Medical Center
  • Washington Hospital Center
  • Florida Cardiovascular Research
  • JFK Medical Center
  • Morton Plant Hospital
  • Holmes Regional Medical Center
  • Cardiovascular Surgeons, P.A.
  • Florida Hospital
  • Orlando Cardiovascular Center, LLLP
  • Orlando Heart Center
  • Orlando Regional Med Center
  • Orlando Heart Center/Sand Lake
  • Clinical Research Center
  • Sarasota Memorial Health Care System
  • Crawford Long Hospital
  • Emory University Hospital
  • St. Elizabeth's Hospital
  • Memorial Hospital
  • Northwestern Medical Facility Foundation
  • Northwestern Memorial Hospital
  • Rush Presbyterian St. Luke's Medical Center
  • Rush Professional Building
  • Resurrection Medical Center
  • Evanston Northwestern Healthcare, Highland Park Hospital
  • Evanston Northwestern Healthcare
  • St. Francis Hospital of Evanston
  • Loyola University Chicago Medical Center
  • Edward Hospital & Health Services
  • Advocate Christ Hospital and Medical Center
  • OSF St. Francis Medical Center
  • Memorial Medical Center
  • Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
  • Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
  • St. John's Hospital
  • Central DuPage Hospital
  • St. Vincent Hospital and Health Care Service
  • The Heart Center of Indiana
  • Genesis Heart Institute
  • Genesis Medical Center
  • Iowa Methodist Medical Center
  • University of Iowa Hospitals and Clinics
  • Georgetown Professional Plaza
  • Shawnee Mission Medical Center
  • Jewish Hospital Health Care Services
  • Maine Medical Center
  • University of Maryland Medical Center
  • Cardiac Surgery Associates
  • Sinai Hospital of Baltimore
  • Johns Hopkins Hospital
  • Peninsula Regional Medical Center
  • Washington Adventist Hospital
  • Cardiac Surgery Associates
  • Midatlantic Cardiovascular Associates, P.A.
  • St. Joseph Medical Center
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Baystate Medical Center
  • McLaren Regional Medical Center
  • Spectrum Health Hospitals
  • Ingham Regional Medical Center
  • Thoracic & Cardiovascular Healthcare Foundation
  • Thoracic & Cardiovascular Institute
  • Cardiology Consultants, PC
  • Great Lakes Cardiothoracic and Vascular Surgery
  • Northern Michigan Hospital
  • Petoskey Cardiology
  • Michigan Cardiovascular Institute
  • Convenant Medical Center
  • St. Mary's/Duluth Clinic Health System
  • Abbott Northwestern Hospital
  • Park Nicollet Institute
  • Methodist Hospital
  • Park Nicollet Heart Center
  • Forrest General Hospital
  • St. John's Regional Medical Center
  • 930 Carondelet Drive
  • Missouri Baptist Medical Center
  • Nebraska Methodist Hospital
  • Nebraska Heart Institute
  • University of Nebraska Medical Center
  • Nebraska Heart Institute
  • Morristown Memorial Hospital
  • Robert Wood Johnson University Hospital
  • Umdnj-Rwjms
  • The Valley Hospital
  • Lenox Hill Hospital
  • New York Presbyterian Medical Center, Milstein Hospital Building
  • Westchester Medical Center
  • University of North Carolina Hospitals
  • Ambulatory Care Center
  • Duke University Medical Center
  • Gaston Memorial Hospital
  • Pitt County Memorial Hospital
  • Brody School of Medicine, East Carolina University
  • FirstHealth Moore Regional Hospital
  • Walley, Morgan & Duncan, M.D., P.A.
  • Forysyth Medical Center
  • MeritCare Clinic at MeritCare Hospital
  • MeritCare Medical Group
  • Akron General Medical Center
  • Aultman Health Foundation
  • Cardiovascular & Thoracic Surgeons
  • Good Samaritan Hospital
  • Bethesda North Hospital
  • Cardiovascular & Thoracic Surgeons, Inc.
  • The Ohio State University Medical Center
  • Riverside Methodist Hospital
  • Kettering Medical Center Network, Kettering Hospital
  • St. Vincent Mercy Medical Center
  • St. Luke's Hospital
  • Penn State Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Presbyterian Hospital, University of Pennsylvania Health System
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center, Presbyterian Hospital
  • Guthrie Clinic
  • Robert Packer Hospital
  • The Chester County Hospital
  • Lankenau Hospital
  • Greenville Hospital System
  • Upstate Cardiothoracic Surgery, Greenville Hospital System
  • Saint Francis Hospital
  • Heart Hospital of Austin
  • Medical City Dallas Hospital
  • Presbyterian Hospital of Dallas
  • St. Paul University Hospital
  • Denton Regional Medical Center
  • Medical Center Plano
  • Southwest Texas Methodist Hospital
  • Northeast Methodist Hospital
  • University of Utah Health Sciences Center
  • Lynchburg General Hospital
  • Sentara Norfolk General Hospital
  • Mid-Atlantic Cardiothoracic Surgeons, Ltd.
  • St. Joseph Hospital
  • Deaconess Medical Center
  • Northwest Heart and Lung Surgical Associates
  • CAMC Health Education and Research Institute, Clinical Trials Center
  • Charleston Area Medical Center
  • Appleton Heart Institute at Appleton Medical Center
  • St. Luke's Medical Center
  • Waukesha Memorial Hospital
  • Community Health Care/Wausau Hospital
  • Wausau Heart and Lung Surgeons

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 22, 2002
Last Updated
May 4, 2006
Sponsor
Anesiva, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00042081
Brief Title
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anesiva, Inc.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, coronary artery bypass surgery, coronary artery disease, coronary arteriosclerosis, coronary stenosis, coronary occlusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CGT003 (E2F Duplex Decoy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Lorenz, M.D.
Organizational Affiliation
Anesiva, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cardio-Thoracic Surgeons, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Baptist Medical Center - Montclair
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Cardio-Thoracic Surgeons, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Cardio-Thoracic Surgeons, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Medical Center East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Seton Medical Center
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desert Regional Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
St. Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
St. Vincent's Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cardiovascular Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Cardiovascular Surgeons, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Cardiovascular Center, LLLP
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Heart Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Regional Med Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Orlando Heart Center/Sand Lake
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Clinical Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Sarasota Memorial Health Care System
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Elizabeth's Hospital
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62220
Country
United States
Facility Name
Memorial Hospital
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Northwestern Medical Facility Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush Professional Building
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Resurrection Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
Evanston Northwestern Healthcare, Highland Park Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
St. Francis Hospital of Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Facility Name
Loyola University Chicago Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Edward Hospital & Health Services
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Advocate Christ Hospital and Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
St. Vincent Hospital and Health Care Service
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
The Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Genesis Heart Institute
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Georgetown Professional Plaza
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Jewish Hospital Health Care Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Cardiac Surgery Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Cardiac Surgery Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Midatlantic Cardiovascular Associates, P.A.
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
McLaren Regional Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Thoracic & Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Thoracic & Cardiovascular Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Cardiology Consultants, PC
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Great Lakes Cardiothoracic and Vascular Surgery
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Petoskey Cardiology
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Michigan Cardiovascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Convenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
St. Mary's/Duluth Clinic Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Park Nicollet Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Methodist Hospital
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Park Nicollet Heart Center
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Forrest General Hospital
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
St. John's Regional Medical Center
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
930 Carondelet Drive
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Missouri Baptist Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Nebraska Heart Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Nebraska Heart Institute
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Umdnj-Rwjms
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Medical Center, Milstein Hospital Building
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27154
Country
United States
Facility Name
Ambulatory Care Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Gaston Memorial Hospital
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Brody School of Medicine, East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Walley, Morgan & Duncan, M.D., P.A.
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forysyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
MeritCare Clinic at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MeritCare Medical Group
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Cardiovascular & Thoracic Surgeons
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cardiovascular & Thoracic Surgeons, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Kettering Medical Center Network, Kettering Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Presbyterian Hospital, University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center, Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
The Chester County Hospital
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Upstate Cardiothoracic Surgery, Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Saint Francis Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
St. Paul University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Denton Regional Medical Center
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Medical Center Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Southwest Texas Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northeast Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Lynchburg General Hospital
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Mid-Atlantic Cardiothoracic Surgeons, Ltd.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
St. Joseph Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Northwest Heart and Lung Surgical Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
CAMC Health Education and Research Institute, Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Appleton Heart Institute at Appleton Medical Center
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Community Health Care/Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Wausau Heart and Lung Surgeons
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16287955
Citation
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.
Results Reference
result
PubMed Identifier
26647082
Citation
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.
Results Reference
derived
PubMed Identifier
25261549
Citation
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.
Results Reference
derived
PubMed Identifier
25073921
Citation
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.
Results Reference
derived
PubMed Identifier
22980305
Citation
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.
Results Reference
derived

Learn more about this trial

Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

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