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PCI with DES for Coronary Artery Disease (SYNTAX Trial)

Phase 3
Waitlist Available
Led By Patrick W. Serruys, MD, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 3 and 5 years post allocation
Awards & highlights

SYNTAX Trial 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).

Eligible Conditions
  • Coronary Artery Disease

SYNTAX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 3 and 5 years post allocation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 3 and 5 years post allocation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-month Composite Safety Endpoint.
Primary Clinical Endpoint of 12-Month Binary MACCE.
Repeat Revascularization (PCI and/or CABG).
Secondary outcome measures
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom From MACCE and Its Components at 3 Years Post-allocation
+7 more

SYNTAX Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PCI with DESExperimental Treatment1 Intervention
Group II: CABG (coronary artery bypass graft)Active Control1 Intervention
Coronary Artery Bypass Graft

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
931,270 Total Patients Enrolled
81 Trials studying Coronary Artery Disease
96,294 Patients Enrolled for Coronary Artery Disease
Cardialysis BVIndustry Sponsor
8 Previous Clinical Trials
919 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
234 Patients Enrolled for Coronary Artery Disease
Monika Hanisch, PhDStudy DirectorBoston Scientific Corporation
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The LancetJournal
Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients with Three-vessel Disease and Left Main Coronary Disease: 5-year Follow-up of the Randomised, Clinical SYNTAX Trial
Mohr, Friedrich W, Marie-Claude Morice, A Pieter Kappetein, Ted E Feldman, Elisabeth Ståhle, Antonio Colombo, Michael J Mack, et al.. 2013. “Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients with Three-vessel Disease and Left Main Coronary Disease: 5-year Follow-up of the Randomised, Clinical SYNTAX Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(13)60141-5.
clinicaltrials.govStudy
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
2005. "SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00114972.
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