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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Ischemic Saphenous Vein Graft Disease
• Intervention / Treatment: Device: Covered Stent System; Device: Bare metal stent

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: Interventional
• Enrollment (Actual): 514
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Symbiot Covered Stent System	Device: Covered Stent System; Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent diameter stenosis at 8 months post-implant	8 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac event rate at 30 days post-implant	30 Days

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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. doi: 10.1002/ccd.20873.

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 27, 2006
• First Submitted That Met QC Criteria: January 27, 2006
• First Posted (Estimate): January 30, 2006

Study Record Updates

• Last Update Posted (Estimate): November 1, 2009
• Last Update Submitted That Met QC Criteria: October 30, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Saphenous Vein Graft; Covered Stent System; Coronary Artery Bypass[MeSH]; Stents[MeSH]
• Other Study ID Numbers: G980213; S2001 (Other Identifier: CTEP)