Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
2 other identifiers
interventional
514
2 countries
49
Brief Summary
The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein bypass graft disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2002
Longer than P75 for not_applicable
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 27, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedNovember 2, 2009
October 1, 2009
2.2 years
January 27, 2006
October 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent diameter stenosis at 8 months post-implant
8 Months
Secondary Outcomes (1)
Major adverse cardiac event rate at 30 days post-implant
30 Days
Study Arms (2)
1
EXPERIMENTALSymbiot Covered Stent System
2
ACTIVE COMPARATORCommercially available bare metal stent
Interventions
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
Eligibility Criteria
You may qualify if:
- Patient \>=18 years old
- Patients is eligible for percutaneous coronary intervention and stenting
- Patient is an acceptable candidate for repeat CABG
- CPK must be within ULN on the day of the procedure
- 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
- 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
- Patient is willing to comply with specified follow-up evaluations at the specified times and locations
- Patient has angina pectoris (CCS 1, 2, 3, or 4) or coronary ischemia documented by a positive functional ischemia study
- Patient has no child bearing potential or has a negative pregnancy test within 7 days prior to treatment
- Target lesion(s) are located within a single SVG
- Reference vessel \>=3.5 mm and \<=5.5mm in diameter at the stent deployment site
- Cumulative target lesion length is \<=41mm
- 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)
- +1 more criteria
You may not qualify if:
- Patient is currently enrolled in another IRB-approved trial that has not reached the primary endpoint visit or is still in the active treatment phase
- Patient has been previously enrolled in any Symbiot Trial
- Patient has documented left ventricular ejection fraction of \<30% within 30 days of enrollment
- Patient has had a myocardial infarction within 48 hours prior to trial procedure and/or CK-MB \>2X the ULN
- 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:
- 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
- days or more after the index procedure is allowed
- The lesion to be treated is within 10 mm of any anastomosis
- Patient has life expectancy of less than 1 year due to other medical conditions
- The lesion(s) to be treated requires debulking prior to stent placement
- Patient has a pre-existing condition for which aspirin is contraindicated
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
University of Alabama Hospital
Birmingham, Alabama, 35294, United States
Baptist Medical Center South
Montgomery, Alabama, 36116, United States
Arizona Heart Institute
Phoenix, Arizona, 85016, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
St. Agnes Medical Center
Fresno, California, 93720, United States
Glendale Memorial Hospital
Glendale, California, 91204, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Palm Beach Heart Research Institute
Atlantis, Florida, 33462, United States
Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Florida Hospital
Orlando, Florida, 32803, United States
University Community Hospital
Tampa, Florida, 33613, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Methodist Hospital
Indianapolis, Indiana, 43202, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Jewish Hospital & St. Mary's Healthcare
Louisville, Kentucky, 40202, United States
Maine Medical Center
Portland, Maine, 04102, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
St. John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Lenox Hill Hospital
New York, New York, 10021, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Presbyterian Healthcare
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Providence Hospital
Columbia, South Carolina, 29204, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Covenant Medical Center
Lubbock, Texas, 79410, United States
Baptist Medical Center
San Antonio, Texas, 78205, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Sacred Heart Medical Center
Spokane, Washington, 99220, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53201, United States
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Related Publications (1)
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.
PMID: 16892434RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Turco, MD
Washington Adventist Hospital, Takoma Park, MD
- PRINCIPAL INVESTIGATOR
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine, La Jolla, CA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 27, 2006
First Posted
January 30, 2006
Study Start
March 1, 2002
Primary Completion
May 1, 2004
Study Completion
March 1, 2009
Last Updated
November 2, 2009
Record last verified: 2009-10