Clinical trial NCT00283413: Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
Official title: Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Ischemic Saphenous Vein Graft Disease
Keywords: Covered Stent System
Saphenous Vein Graft
Coronary Artery Bypass[MeSH]
Stents[MeSH]
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percent diameter stenosis at 8 months post-implant
timeFrame: 8 Months
Secondary outcomes:
measure: Major adverse cardiac event rate at 30 days post-implant
timeFrame: 30 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Montgomery
country: United States
facility: Baptist Medical Center South
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Fresno
country: United States
facility: St. Agnes Medical Center
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Palm Beach Heart Research Institute
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital & St. Mary's Healthcare
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Healthcare
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Providence Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Lubbock
country: United States
facility: Covenant Medical Center
state: Texas
city: San Antonio
country: United States
facility: Baptist Medical Center
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Washington Adventist Hospital, Takoma Park, MD
name: Mark Turco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation for Cardiovascular Medicine, La Jolla, CA
name: Maurice Buchbinder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.