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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283413
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : November 2, 2009
Sponsor:
Information provided by:
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE January 27, 2006
First Posted Date  ICMJE January 30, 2006
Last Update Posted Date November 2, 2009
Study Start Date  ICMJE March 2002
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Percent diameter stenosis at 8 months post-implant [ Time Frame: 8 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
% stent stenosis at 8 month QCA measurement
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Major adverse cardiac event rate at 30 days post-implant [ Time Frame: 30 Days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
Official Title  ICMJE Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Ischemic Saphenous Vein Graft Disease
Intervention  ICMJE
  • Device: Covered Stent System
    Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
    Other Name: Symbiot Covered Stent System
  • Device: Bare metal stent
    Any commercially available bare metal stent for coronary indication
Study Arms  ICMJE
  • Experimental: 1
    Symbiot Covered Stent System
    Intervention: Device: Covered Stent System
  • Active Comparator: 2
    Commercially available bare metal stent
    Intervention: Device: Bare metal stent
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
514
Original Enrollment  ICMJE
 (submitted: January 27, 2006)
400
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283413
Other Study ID Numbers  ICMJE G980213
S2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Albert/Clinical Project Manager, Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Turco, MD Washington Adventist Hospital, Takoma Park, MD
Principal Investigator: Maurice Buchbinder, MD Foundation for Cardiovascular Medicine, La Jolla, CA
PRS Account Boston Scientific Corporation
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP