A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 450
Summary
- Conditions
- 3 Vessel Coronary Artery Disease
- Cardiovascular Diseases
- Heart Diseases
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
The purpose of the SYNTAX II Trial is to investigate the management of de-novo 3-vessel-disease in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between coronary artery bypass graft and percutaneous coronary intervention (PCI), usin...
The purpose of the SYNTAX II Trial is to investigate the management of de-novo 3-vessel-disease in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between coronary artery bypass graft and percutaneous coronary intervention (PCI), using contemporary PCI practice. In SYNTAX II the effectiveness of a contemporary stent (designed with thinner struts, biocompatible and biodegradable polymer, and a limus based drug), the use of pressure wire assessment of lesions to allow for ischemia-driven revascularisation, intravascular ultrasound (IVUS) guidance to optimise drug eluting stent deployment, and the treatment of (chronic) total occlusion lesions with contemporary techniques, will be compared against PCI practice in the original SYNTAX trial. The proposed study would involve the SYNTAX Score II to prospectively recruit subjects on the grounds of patient safety
Tracking Information
- NCT #
- NCT02015832
- Collaborators
- Boston Scientific Corporation
- Volcano Corporation
- Investigators
- Study Chair: Patrick Serruys, Prof. MD. Thoraxcenter, Erasmus, The Netherlands Principal Investigator: Javier Escaned, MD Hospital San Carlos Madrid, Spain Principal Investigator: Adrian Banning, MD John Radcliffe Hospital, Oxford, United Kingdom Principal Investigator: Arie-Pieter Kappetein, MD Thorax center, Erasmus, The Netherlands Principal Investigator: David Taggart, MD John Radcliffe Hospital, Oxford. United Kingdom Principal Investigator: Vasim Farooq, MD Manchester Royal Infirmary, United Kingdom
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