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Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00283413
First received: January 27, 2006
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Symptomatic Ischemic Saphenous Vein Graft Disease
Device: Covered Stent System
Device: Bare metal stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Percent diameter stenosis at 8 months post-implant [ Time Frame: 8 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiac event rate at 30 days post-implant [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Enrollment: 514
Study Start Date: March 2002
Study Completion Date: March 2009
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Symbiot Covered Stent System
Device: Covered Stent System
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
Other Name: Symbiot Covered Stent System
Active Comparator: 2
Commercially available bare metal stent
Device: Bare metal stent
Any commercially available bare metal stent for coronary indication

Detailed Description:

Symbiot III was a prospective, multi-center, randomized, controlled trial to evaluate the safety and efficacy of the Symbiot stent compared to bare metal stents in the treatment of symptomatic ischemic saphenous vein graft disease. Randomization was stratified by the intended use of intravenous glycoprotein IIb/IIIa inhibitors and by the intended use of approved distal protection to ensure approximate balance between study treatments within each of the strata. The primary outcome variable for the study was target lesion percent diameter stenosis at 8 months post-implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Patient >=18 years old
  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

Angiographic Inclusion Criteria:

  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%

General Exclusion Criteria:

  1. 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
  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

Angiographic Exclusion Criteria:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283413

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
University of Alabama Hospital
Birmingham, Alabama, United States, 35294
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85016
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
St. Agnes Medical Center
Fresno, California, United States, 93720
Glendale Memorial Hospital
Glendale, California, United States, 91204
Scripps Memorial Hospital
La Jolla, California, United States, 92037
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Mercy General Hospital
Sacramento, California, United States, 95819
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Palm Beach Heart Research Institute
Atlantis, Florida, United States, 33462
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Florida Hospital
Orlando, Florida, United States, 32803
University Community Hospital
Tampa, Florida, United States, 33613
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 43202
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Jewish Hospital & St. Mary's Healthcare
Louisville, Kentucky, United States, 40202
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Michigan
St. John Hospital & Medical Center
Detroit, Michigan, United States, 48236
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10021
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Medical Center
Raleigh, North Carolina, United States, 27610
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Providence Hospital
Columbia, South Carolina, United States, 29204
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Covenant Medical Center
Lubbock, Texas, United States, 79410
Baptist Medical Center
San Antonio, Texas, United States, 78205
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99220
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53201
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Mark Turco, MD Washington Adventist Hospital, Takoma Park, MD
Principal Investigator: Maurice Buchbinder, MD Foundation for Cardiovascular Medicine, La Jolla, CA
  More Information

Publications:
Responsible Party: Matthew Albert/Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00283413     History of Changes
Other Study ID Numbers: G980213, S2001
Study First Received: January 27, 2006
Last Updated: October 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Covered Stent System
Saphenous Vein Graft
Coronary Artery Bypass[MeSH]
Stents[MeSH]

ClinicalTrials.gov processed this record on November 23, 2014