Peripheral Vascular DiseasesPhase 2/3NCT00041925
Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures
A Phase 2/3 study testing CGT003 (E2F Duplex Decoy) in people with Peripheral Vascular Diseases and Arterial Occlusive Diseases, run by Anesiva, Inc. at 123 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Ischemia
- What is being tested?
- CGT003 (E2F Duplex Decoy)
- How many people
- 1,400 participants
- Where
- 123 sitesin 2 countries
- Study dates
- Nov 2001to Nov 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PATIENTS MUST:
- 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).
- Be males or females of at least 18 years old.
- Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.
- 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.
- Note: Patients undergoing operations to replace previously occluded grafts that involve placement of an entirely new bypass graft ARE eligible for this study.
Trial locations and contacts
123 sites in 2 countries.
123 sites in 2 countries
United States116 sites
Albany Medical Center
Albany, New York, 12208
Emory University School of Medicine Hospital
Atlanta, Georgia, 30322
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Vascular Institute of Georgia
Atlanta, Georgia, 30342
University of Maryland Hospital
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
The Kirklin Clinic
Birmingham, Alabama, 35233
University Hospital
Birmingham, Alabama, 35294
New England Medical Center Hospital
Boston, Massachusetts, 02111
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dept. of Surgery at Harvard Medical Faculty Physicians
Boston, Massachusetts, 02215
Kings County Hospital
Brooklyn, New York, 11203
SUNY Downstate University Hospital of Brooklyn and Medical School
Brooklyn, New York, 11203
Maimonides Medical Center
Brooklyn, New York, 11219
Medical University of South Carolina Hospital
Charleston, South Carolina, 29425
Vascular and Transplant Specialists, Peripheral Vascular Laboratory
Chesapeake, Virginia, 23320
Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory
Chesapeake, Virginia, 23320
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Atlanta VA Medical Center
Decatur, Georgia, 30033
Kaiser Permanente Franklin Medical Center
Denver, Colorado, 80205
Exempla Healthcare Saint Joseph Hospital
Denver, Colorado, 80218
Southampton Memorial Hospital
Franklin, Virginia, 23851
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
Gaston Memorial Hospital
Gastonia, North Carolina, 28054
Pitt County Memorial Hospital
Greenville, North Carolina, 27834
Department of Surgery, Division of Vascular Surgery, East Carolina University
Greenville, North Carolina, 27858
Hartford Hospital
Hartford, Connecticut, 06102
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Dr. Randy Shafrtiz, Clinical Office
Holmdel, New Jersey, 07733
Baylor College of Medicine
Houston, Texas, 77030
VAMC
Houston, Texas, 77030
Methodist Hospital
Indianapolis, Indiana, 46202
Veteran's Affairs Medical Center
Indianapolis, Indiana, 46202
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Health
Little Rock, Arkansas, 72205
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences Hospital
Little Rock, Arkansas, 72205
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University Medical Center
Lubbock, Texas, 79415
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Froedert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, 53295
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Vascular Specialists of Mobile, PC
Mobile, Alabama, 36607
Springhill Memorial Hopsital
Mobile, Alabama, 36608
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Surgical Specialists of NJ, Morris Vascular Center
Morristown, New Jersey, 07960
St. Thomas Medical
Nashville, Tennessee, 37205
The Surgical Group, PLLC
Nashville, Tennessee, 37205
Shore Memorial Hospital
Nassawadox, Virginia, 23413
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Umdnj-Rwjms
New Brunswick, New Jersey, 08903
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
Columbia Presbyterian Medical Center
New York, New York, 10032
UMDNJ - New Jersey Medical School, University Hospital
Newark, New Jersey
Chesapeake General Hospital
Norfolk, Virginia, 23502
Vascular and Transplant Specialists, Peripheral Vascular Laboratory
Norfolk, Virginia, 23502
Virginia Vascular Associates
Norfolk, Virginia, 23502
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Vascular and Transplant Specialists, Peripheral Vascular Laboratory
Norfolk, Virginia, 23510
Methodist Hospital
Omaha, Nebraska, 68114
VA Palo Alto Health Care System
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Veterans Administration Healthcare System
Pittsburgh, Pennsylvania, 15240
Maine Medical Center
Portland, Maine, 04102
Oregon Health Sciences University
Portland, Oregon, 97201
Rhode Island Hospital
Providence, Rhode Island, 02905
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24014
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Jefferson Surgical Clinic
Roanoke, Virginia, 24016
St. Mary's Hospital
Rochester, Minnesota, 55902
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Lakeland Hospital
Saint Joseph, Michigan, 49085
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Baptist Medical Center
San Antonio, Texas, 78205
Peripheral Vascular Associates
San Antonio, Texas, 78215
Northeast Baptist Hospital
San Antonio, Texas, 78217
Peripheral Vascular Associates
San Antonio, Texas, 78217
Pro-Research Group
San Antonio, Texas, 78224
Southwest Texas Methodist Hospital
San Antonio, Texas, 78229
Kaiser Permanente - San Diego, SCPMG, Department of Surgery
San Diego, California, 92120
Samson Showalter Vascular Specialists
Sarasota, Florida, 34233
Clinical Research Center
Sarasota, Florida, 34239
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Vascular & Surgery Assoc.
Sarasota, Florida, 34239
Robert Packer Hospital
Sayre, Pennsylvania, 18840
Harborview Medical Center
Seattle, Washington, 98104
VA Puget Sound Health Care System
Seattle, Washington, 98108
University of Washington Medical Center
Seattle, Washington, 98195
O.W. Brown, M.D.
Southfield, Michigan, 48075
Washington University School of Medicine
St Louis, Missouri, 63110
Flower Hospital
Sylvania, Ohio, 43560
Tampa General Hospital
Tampa, Florida, 33601
Montefiore Hospital
The Bronx, New York, 10467
Jobst Vascular Center
Toledo, Ohio, 43606
The Toledo Hospital
Toledo, Ohio, 43606
Steven D. Rimar, M.D.
Troy, Michigan, 48098
Tucson Heart Hospital
Tucson, Arizona, 85704
University Medical Center
Tucson, Arizona, 85724
Northwest Hospital
Tucson, Arizona, 85741
Tucson Vascular Surgery
Tucson, Arizona, 85741
Southern Arizona Vascular Institute
Tucson, Arizona, 85745
St. Mary's Hospital
Tucson, Arizona, 85745
Washington Hospital Center, Center for Vascular Care
Washington D.C., District of Columbia, 20010
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Canada7 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y6J4
London Health Sciences Centre
London, Ontario, N6A 4G5
Ottawa Hospital
Ottawa, Ontario, KIY 4E9
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
University Health Network
Toronto, Ontario, M5G 2C4
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, V5Z 1M9
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Peripheral Vein Grafts in Patients Undergoing Peripheral Arterial Bypass Graft Procedures
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).
Read the detailed description
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.
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Ischemia, Graft Occlusion, Vascular, Hyperplasia
- Being tested
- CGT003 (E2F Duplex Decoy)
- Keywords
- atherosclerotic vascular disease, chronic critical limb ischemia, neointimal hyperplasia, peripheral vein bypass, infra-inguinal bypass grafting surgery, graft stenosis, occluded grafts
- Medical subject headings
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Ischemia, Graft Occlusion, Vascular, Hyperplasia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGT003 (E2F Duplex Decoy)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2002 (estimated)
- Study startNov 2001
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Todd Lorenz, M.D., Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041925
- Sponsor's protocol ID
- CGT003-03
- Status last verified
- Jul 2005
- First submitted
- 18 Jul 2002
- Last updated
- 15 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Peripheral Vein Grafts in Patients Undergoing Peripheral Arterial Bypass Graft Procedures
- ClinicalTrials.gov ID
- NCT00041925
- Acronym / sponsor ID
- CGT003-03
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Ischemia, Graft Occlusion, Vascular, Hyperplasia
- Keywords
- atherosclerotic vascular disease, chronic critical limb ischemia, neointimal hyperplasia, peripheral vein bypass, infra-inguinal bypass grafting surgery, graft stenosis, occluded grafts
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Nov 2004
- First posted
- 22 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGT003 (E2F Duplex Decoy) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Lorenz, M.D. study director
Anesiva, Inc.
123 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CGT003 (E2F Duplex Decoy) in people with Peripheral Vascular Diseases and Arterial Occlusive Diseases, run by Anesiva, Inc. at 123 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 123 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2005.