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Sponsors and Collaborators: |
Boston Scientific Corporation Cardialysis BV |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00114972 |
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 |
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Coronary Artery Disease |
Device: Polymer-based Paclitaxel-Eluting TAXUS Express-SR Stent Procedure: Coronary Artery Bypass Surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery |
Enrollment: | 1800 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: Polymer-based Paclitaxel-Eluting TAXUS Express-SR Stent
Drug Eluting Stent
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2: Active Comparator |
Procedure: Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Medical City Hospital Dallas | |
Dallas, Texas, United States, 75230 |
Principal Investigator: | Patrick W. Serruys, MD, PhD | Erasmus University Medical Center Rotterdam |
Principal Investigator: | Friedrich W Mohr, MD | University of Leipzig |
Study Director: | Xavier Lefebvre, PhD | Boston Scientific Corporation |
Responsible Party: | Boston Scientific ( Nic Van Dyck ) |
Study ID Numbers: | 90169394, S2024 |
Study First Received: | June 20, 2005 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00114972 |
Health Authority: | United States: Food and Drug Administration |
Three-vessel coronary artery disease Left main coronary artery disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |