NCT02015832

Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI

Single-arm Trial Evaluating the Effectiveness of PCI of de Novo 3-vessel Disease Applying the SYNTAX Score II With Pressure Wire Functional Assessment and IVUS Guidance, Using an Everolimus-eluting Stent With Biodegradable Abluminal Coating

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 454 (actual)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)

Detailed 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), 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

Conditions

• Heart Diseases
• Cardiovascular Diseases
• 3 Vessel Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coronary stent
RADIATION	Multi Slice Computed Tomography	A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
DEVICE	instantaneous wave-free ratio	Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
DEVICE	Fractional flow reserve	Pressure-derived index on physiological assessment of stenosis severity
DEVICE	Intravascular Ultrasound	Allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, visualizing the inner wall of blood vessels

Timeline

• Start date: 2014-02-06
• Primary completion: 2017-03-28
• Completion: 2021-02-04
• First posted: 2013-12-19
• Last updated: 2022-07-21
• Results posted: 2022-06-16

Locations

22 sites across 4 countries: Netherlands, Poland, Spain, United Kingdom