SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Boston Scientific Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cardialysis BV
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00114972
First received: June 20, 2005
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).


Condition Intervention Phase
Coronary Artery Disease
Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Procedure: Coronary Artery Bypass Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: Yes ]
    Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).

  • 12-month Composite Safety Endpoint. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: Yes ]
    Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.

  • Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ] [ Designated as safety issue: Yes ]
    Number of participants with repeat revascularization (PCI and/or CABG).


Secondary Outcome Measures:
  • Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation. [ Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.

  • Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 1 month after procedure ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 6 months post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).

  • Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ] [ Designated as safety issue: Yes ]
  • Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ] [ Designated as safety issue: Yes ]
  • Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation [ Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation ] [ Designated as safety issue: No ]
  • Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ] [ Designated as safety issue: No ]
  • The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible) [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Enrollment: 1800
Study Start Date: March 2005
Estimated Study Completion Date: May 2012
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI with DES Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Drug Eluting Stent
Other Names:
  • Percutaneous coronary intervention
  • Paclitaxel eluting stent
  • 3 vessel disease
  • Left main stem
Active Comparator: CABG (coronary artery bypass graft)
Coronary Artery Bypass Graft
Procedure: Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery
Other Names:
  • Coronary artery disease
  • Coronary artery bypass graft
  • Left Main coronary artery

Detailed Description:

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
  • De novo lesions with at least 50% stenosis
  • Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

  • Prior PCI or CABG
  • Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
  • Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
  • Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
  • Inability to give informed consent due to mental condition, mental retardation, or language barrier
  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: NCT00114972

  Hide Study Locations
Locations
United States, California
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
Florida Cardiovascular Research
Atlantis, Florida, United States, 33462
Ocala Heart Institue
Ocala, Florida, United States, 34474
Munroe Medical Center
Ocala, Florida, United States, 34474
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
Evanston Hospital
Evanston, Illinois, United States, 60201
Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
Rockford, Illinois, United States, 61108-2465
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Cape Cod Research Institute
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
St. Mary's Hospital
Rochester, Minnesota, United States, 55905
United States, New York
SUNY - Stony Brook School of Medicine
Stony Brook, New York, United States, 11794
SJH Cardiology Associates
Syracuse, New York, United States, 13203
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
United States, North Carolina
Cardiovascular and Thoracic Surgeons of Greensboro
Greensboro, North Carolina, United States, 27405
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27401
Wake Medical Center
Raleigh, North Carolina, United States, 27610
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
St. Mary's Medical Center
Langhorne, Pennsylvania, United States, 19047
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
San Antonio Endovascular Heart Institue
San Antonio, Texas, United States, 78205
United States, Virginia
Sentara Norfolk General Hospital 1st Fl
Norfolk, Virginia, United States, 23507
Austria
Univ. Klinik für Herzchirurgie Landeskliniken
Salzburg, Austria, A-5020
Allgemeines Krankenhaus AKH
Vienna, Austria, A-1090
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, B-9300
Academisch Ziekenhuis Middelheim
Antwerpen, Belgium, B-2020
Universitair Ziekenhuis
Gent, Belgium, B-9000
Centre Hôpital Universitaire Sart Tilman
Liège, Belgium, B-4000
Czech Republic
Interni Klinika VFN
Praha, Czech Republic, CZ-128 08
University Hospital Vinohrady
Praha, Czech Republic, CZ-100 34
Denmark
Skejby Sygehus
Aarhus, Denmark, D-8200
Finland
Helsinki University Central Hospital
Helsinki, Finland, FIN-00290 HUS
University of Helsinki Meilahti Hospital
Helsinki, Finland, FIN-00290 HUS
France
Clinique St Augustin
Bordeaux, France, 33000
Institut Cardiovasculaire Paris Sud - Massy
Massy, France, F-91349
Clinique Saint-Hilaire Rouen
Rouen, France, 76000
Centre Hopital Universitaire Rouen - Hopital Charles Nicolle
Rouen Cedex, France, 76031
Clinique Pasteur
Toulouse, France, 31076
Centre Hôpital Universitaire Rangueil
Toulouse, France, 31403
CHU Rangueil
Toulouse Cedex 9, France, 31059
Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany, 32545
Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany, D-13353
Universitatsklinik Charite Berlin, Campus Mitte
Berlin, Germany, 10117
Campus Virchow Klinikum Herzkatheterlabor
Berlin, Germany, 13353
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Universitätsklinikum Campus Kiel
Kiel, Germany, 24105
Herzzentrum Universität Leipzig
Leipzig, Germany, D-04289
Medizinische Universitaet Luebeck
Lübeck, Germany, 23538
Klinikum Grosshadern
München, Germany, D-81337
Krankenhaus der Barmherzigen Brüder
Trier, Germany, D-54292
Hungary
National Medical Center
Budapest, Hungary, 1134
University of Debrecen, Medical and Health Science Center
Debrecen, Hungary, 4032
Medical School of University PECS
Pecs, Hungary, 1135
Italy
Ospedale Riuniti di Bergamo
Bergamo, Italy, 24128
Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale
Massa, Italy, 54100
Ospedale San Raffaele
Milan, Italy, 20132
Ospedale Civile di Mirano
Mirano, Italy, 30035
Policlinico San Matteo
Pavia, Italy, 27100
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Policlinico Agostino Gemelli
Roma, Italy, 00161
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Latvia
P. Stradins University Hospital
Riga, Latvia, LV-1002
Netherlands
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
Erasmus MC - University Medical Center Rotterdam
Rotterdam, Netherlands, 3000 CA
Isala Klinieken, De Weezenlanden
Zwolle, Netherlands, 8011 JW
Norway
Rikshospitalet
Oslo, Norway, 0027
Poland
Medical University of Silesia - Katowice
Katowice, Poland, 40635
Jagiellonian University of Cardiology
Krakow, Poland, 31-501
John Paul II Hospital
Krakow, Poland, 31-202
National Institute of Cardiology
Warsaw, Poland, 04-628
Portugal
Hospital de Santa Marta
Lisboa, Portugal, 1169-024
Spain
Hospital General Universitario
Alicante, Spain, 03010
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Clinico Y Provincial
Barcelona, Spain, ES-08036
Hospital Clinico San Carlos
Madrid, Spain, ES-28040
Hospital Clinico Salamanca
Salamanca, Spain, 37008
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41345
University Hospital of Lund
Lund, Sweden, SE-221 85
Lund University Hospital
Lund, Sweden, SE-22181
Karolinska Universitets Sjukhuset - Stockholm
Stockholm, Sweden, SE-171 76
Akademiska sjukhuset
Uppsala, Sweden, SE-75185
University Hospital Uppsala
Uppsala, Sweden, SE-75185
United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 1ES
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
University Hospitals of Leicester NHS Trust Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
King's College Hospital London
London, United Kingdom, SE5 9RS
St Thomas Hospital
London, United Kingdom, SE1 7EH
London Chest Hospital
London, United Kingdom, E2 9JX
John Radcliffe Infirmary Oxford II
Oxford, United Kingdom, OX3 9DU
Southampton University Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Boston Scientific Corporation
Cardialysis BV
Investigators
Principal Investigator: Patrick W. Serruys, MD, PhD Erasmus University Medical Center Rotterdam
Principal Investigator: Friedrich W Mohr, MD University of Leipzig
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nic Van Dyck, Boston Scientific
ClinicalTrials.gov Identifier: NCT00114972     History of Changes
Other Study ID Numbers: S2024, 90169394
Study First Received: June 20, 2005
Results First Received: March 27, 2009
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Three-vessel coronary artery disease
Left main coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014