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

Last updated: May 27, 2010
Sponsor: Boston Scientific Corporation
Overall Status: Trial Status Unknown

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00114972
S2024
90169394
  • Ages > 21
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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 orreplacement)

  • 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, orlanguage barrier

Study Design

Total Participants: 1800
Study Start date:
March 01, 2005
Estimated Completion Date:
May 31, 2012

Study 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.

Connect with a study center

  • Univ. Klinik für Herzchirurgie Landeskliniken

    Salzburg, A-5020
    Austria

    Site Not Available

  • Allgemeines Krankenhaus AKH

    Vienna, A-1090
    Austria

    Site Not Available

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, B-9300
    Belgium

    Site Not Available

  • Academisch Ziekenhuis Middelheim

    Antwerpen, B-2020
    Belgium

    Site Not Available

  • Universitair Ziekenhuis

    Gent, B-9000
    Belgium

    Site Not Available

  • Centre Hôpital Universitaire Sart Tilman

    Liège, B-4000
    Belgium

    Site Not Available

  • Centre Hôpital Universitaire Sart Tilman

    Liège, B-4000
    Belgium

    Site Not Available

  • Interni Klinika VFN

    Praha, CZ-128 08
    Czech Republic

    Site Not Available

  • University Hospital Vinohrady

    Praha, CZ-100 34
    Czech Republic

    Site Not Available

  • Skejby Sygehus

    Aarhus, D-8200
    Denmark

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, FIN-00290 HUS
    Finland

    Site Not Available

  • University of Helsinki Meilahti Hospital

    Helsinki, FIN-00290 HUS
    Finland

    Site Not Available

  • Clinique St Augustin

    Bordeaux, 33000
    France

    Site Not Available

  • Institut Cardiovasculaire Paris Sud - Massy

    Massy, F-91349
    France

    Site Not Available

  • Clinique Saint-Hilaire Rouen

    Rouen, 76000
    France

    Site Not Available

  • Centre Hopital Universitaire Rouen - Hopital Charles Nicolle

    Rouen Cedex, 76031
    France

    Site Not Available

  • Centre Hôpital Universitaire Rangueil

    Toulouse, 31403
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

  • CHU Rangueil

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Campus Virchow Klinikum Herzkatheterlabor

    Berlin, 13353
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum

    Berlin, D-13353
    Germany

    Site Not Available

  • Universitatsklinik Charite Berlin, Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinik Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Herzzentrum Universität Leipzig

    Leipzig, D-04289
    Germany

    Site Not Available

  • Medizinische Universitaet Luebeck

    Lübeck, 23538
    Germany

    Site Not Available

  • Medizinische Universitaet Luebeck

    Lübeck, 23538
    Germany

    Site Not Available

  • Klinikum Grosshadern

    München, D-81337
    Germany

    Site Not Available

  • Klinikum Grosshadern

    München, D-81337
    Germany

    Site Not Available

  • Krankenhaus der Barmherzigen Brüder

    Trier, D-54292
    Germany

    Site Not Available

  • National Medical Center

    Budapest, 1134
    Hungary

    Site Not Available

  • University of Debrecen, Medical and Health Science Center

    Debrecen, 4032
    Hungary

    Site Not Available

  • Medical School of University PECS

    Pecs, 1135
    Hungary

    Site Not Available

  • Ospedale Riuniti di Bergamo

    Bergamo, 24128
    Italy

    Site Not Available

  • Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale

    Massa, 54100
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Ospedale Civile di Mirano

    Mirano, 30035
    Italy

    Site Not Available

  • IRCCS Policlinico S. Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Policlinico Agostino Gemelli

    Roma, 00161
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • P. Stradins University Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • Amphia Ziekenhuis

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • St. Antonius Hospital

    Nieuwegein, 3435 CM
    Netherlands

    Site Not Available

  • Erasmus MC - University Medical Center Rotterdam

    Rotterdam, 3000 CA
    Netherlands

    Site Not Available

  • Isala Klinieken, De Weezenlanden

    Zwolle, 8011 JW
    Netherlands

    Site Not Available

  • Rikshospitalet

    Oslo, 0027
    Norway

    Site Not Available

  • Medical University of Silesia - Katowice

    Katowice, 40635
    Poland

    Site Not Available

  • Jagiellonian University of Cardiology

    Krakow, 31-501
    Poland

    Site Not Available

  • John Paul II Hospital

    Krakow, 31-202
    Poland

    Site Not Available

  • National Institute of Cardiology

    Warsaw, 04-628
    Poland

    Site Not Available

  • Hospital de Santa Marta

    Lisboa, 1169-024
    Portugal

    Site Not Available

  • Hospital General Universitario

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital General de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Clinico Y Provincial

    Barcelona, ES-08036
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, ES-28040
    Spain

    Site Not Available

  • Hospital Clinico Salamanca

    Salamanca, 37008
    Spain

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg, 41345
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg, 41345
    Sweden

    Site Not Available

  • Lund University Hospital

    Lund, SE-22181
    Sweden

    Site Not Available

  • University Hospital of Lund

    Lund, SE-221 85
    Sweden

    Site Not Available

  • Karolinska Universitets Sjukhuset - Stockholm

    Stockholm, SE-171 76
    Sweden

    Site Not Available

  • Akademiska sjukhuset

    Uppsala, SE-75185
    Sweden

    Site Not Available

  • University Hospital Uppsala

    Uppsala, SE-75185
    Sweden

    Site Not Available

  • Royal Sussex County Hospital

    Brighton, East Sussex BN2 1ES
    United Kingdom

    Site Not Available

  • Western Infirmary

    Glasgow, G11 6NT
    United Kingdom

    Site Not Available

  • Glenfield Hospital

    Leicester, LE3 9QP
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust Glenfield Hospital

    Leicester, LE3 9QP
    United Kingdom

    Site Not Available

  • King's College Hospital London

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • London Chest Hospital

    London, E2 9JX
    United Kingdom

    Site Not Available

  • St Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • John Radcliffe Infirmary Oxford II

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Southampton University Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Mercy General Hospital

    Sacramento, California 95819
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Florida Cardiovascular Research

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Munroe Medical Center

    Ocala, Florida 34474
    United States

    Site Not Available

  • Ocala Heart Institue

    Ocala, Florida 34474
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Rockford Cardiology Research Foundation (St. Anthony's Medical Center)

    Rockford, Illinois 61108-2465
    United States

    Site Not Available

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Tufts New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Cape Cod Hospital

    Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Cape Cod Research Institute

    Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Genesys Regional Medical Center

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. Mary's Hospital

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • SUNY - Stony Brook School of Medicine

    Stony Brook, New York 11794
    United States

    Site Not Available

  • SJH Cardiology Associates

    Syracuse, New York 13203
    United States

    Site Not Available

  • St. Joseph's Hospital Health Center

    Syracuse, New York 13203
    United States

    Site Not Available

  • Cardiovascular and Thoracic Surgeons of Greensboro

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Wake Medical Center

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • St. Mary's Medical Center

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Medical City Dallas Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • San Antonio Endovascular Heart Institue

    San Antonio, Texas 78205
    United States

    Site Not Available

  • Sentara Norfolk General Hospital 1st Fl

    Norfolk, Virginia 23507
    United States

    Site Not Available

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