Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
NCT ID: NCT00283413
Last Updated: 2009-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
514 participants
INTERVENTIONAL
2002-03-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Symbiot Covered Stent System
Covered Stent System
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
2
Commercially available bare metal stent
Bare metal stent
Any commercially available bare metal stent for coronary indication
Interventions
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Covered Stent System
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
Bare metal stent
Any commercially available bare metal stent for coronary indication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients is eligible for percutaneous coronary intervention and stenting
3. Patient is an acceptable candidate for repeat CABG
4. CPK must be within ULN on the day of the procedure
5. Patient must meet one of the following requirements:
* treatment of one or two de novo or restenotic lesions in a single SVG
* treatment of both a native coronary artery and the target graft in a single procedure, provided that the native artery is treated prior to randomization of the target lesion(s) and did not result in MACE or TIMI flow \<3
6. Patients (or their legal representative) understands the nature of the procedure and study requirements and provides written informed consent before any study specific tests or procedures are performed
7. Patient is willing to comply with specified follow-up evaluations at the specified times and locations
8. Patient has angina pectoris (CCS 1, 2, 3, or 4) or coronary ischemia documented by a positive functional ischemia study
9. Patient has no child bearing potential or has a negative pregnancy test within 7 days prior to treatment
1. Target lesion(s) are located within a single SVG
2. Reference vessel \>=3.5 mm and \<=5.5mm in diameter at the stent deployment site
3. Cumulative target lesion length is \<=41mm
4. Target lesion(s) randomized to treatment with the study device must be completely covered by 1 or 2 stents (maximum allowable aggregate stent length in target vessel of 51 mm)
5. Target lesion stenosis \>=50% and \<100%
Exclusion Criteria
2. Patient has been previously enrolled in any Symbiot Trial
3. Patient has documented left ventricular ejection fraction of \<30% within 30 days of enrollment
4. Patient has had a myocardial infarction within 48 hours prior to trial procedure and/or CK-MB \>2X the ULN
5. Patient has had, or will have, a planned additional interventional procedure to any coronary vessel (coronary artery or saphenous vein graft) that does not meet the following criteria:
If the staged procedure is chosen for non-study percutaneous intervention to any non-target vessel:
* 30 days or more prior to the index procedure is allowed
* Between 24 hours and 30 days prior to the index procedure is allowed provided that no major adverse cardiac events resulted from the staged non-study procedure
* Within 24 hours prior to the index procedure not allowed
* Within 30 days after the index procedure is not allowed
* 30 days or more after the index procedure is allowed
6. The lesion to be treated is within 10 mm of any anastomosis
7. Patient has life expectancy of less than 1 year due to other medical conditions
8. The lesion(s) to be treated requires debulking prior to stent placement
9. Patient has a pre-existing condition for which aspirin is contraindicated
10. Patient has a pre-existing condition for which clopidogrel and ticlopidine are contraindicated
11. Patient has a known hypersensitivity to nickel
1. Target vessel is a left main artery-equivalent graft
2. Target vessel is an internal mammary artery graft
3. Target lesion(s) have any intraluminal thrombus present with TIMI flow \<3
4. Target vessel has excessive tortuousity unsuitable for delivery and deployment of Symbiot
5. Target lesion(s) is/are within a previous stented segment
6. Target or non-target vessel requires pre-treatment with an adjunctive non-balloon device (e.g., DCA, TEC, Rotablator or laser) prior to stent placement during the stent placement procedure
7. Treatment with non-approved distal protection systems
8. Target lesion(s) involve either the ostium or distal anastomosis
9. Target lesion(s) are at or immediately distal to a \>45 degree bend in the vessel
10. Target vessel is a degenerated SVG (diffuse segments of disease \>41 mm in length with stenosis, ectasia and probable thrombus)
11. Untreated lesions are present proximal or distal to the target site which may compromise inflow or outflow of the treatment site after stent deployment
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Boston Scientific Corporation
Principal Investigators
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Mark Turco, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Adventist Hospital, Takoma Park, MD
Maurice Buchbinder, MD
Role: PRINCIPAL_INVESTIGATOR
Foundation for Cardiovascular Medicine, La Jolla, CA
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
University of Alabama Hospital
Birmingham, Alabama, United States
Baptist Medical Center South
Montgomery, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
St. Agnes Medical Center
Fresno, California, United States
Glendale Memorial Hospital
Glendale, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Palm Beach Heart Research Institute
Atlantis, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
University Community Hospital
Tampa, Florida, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Methodist Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Jewish Hospital & St. Mary's Healthcare
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
St. Joseph Medical Center
Towson, Maryland, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Lenox Hill Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Providence Hospital
Columbia, South Carolina, United States
Memorial Hospital
Chattanooga, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Covenant Medical Center
Lubbock, Texas, United States
Baptist Medical Center
San Antonio, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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References
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Turco MA, Buchbinder M, Popma JJ, Weissman NJ, Mann T, Doucet S, Johnson WL Jr, Greenberg JD, Leadley K, Russell ME. Pivotal, randomized U.S. study of the Symbiottrade mark covered stent system in patients with saphenous vein graft disease: eight-month angiographic and clinical results from the Symbiot III trial. Catheter Cardiovasc Interv. 2006 Sep;68(3):379-88. doi: 10.1002/ccd.20873.
Other Identifiers
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S2001
Identifier Type: -
Identifier Source: secondary_id
G980213
Identifier Type: -
Identifier Source: org_study_id
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