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

NCT02015832 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 454

Last updated 2022-07-21

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Volcano Corporation

    collaborator INDUSTRY
  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • Ernest Spitzer, MD · European Cardiovascular Research Institute

  • Javier Escaned, MD · Hospital San Carlos Madrid, Spain

  • Adrian Banning, MD · John Radcliffe Hospital, Oxford, United Kingdom

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-06
Primary Completion
2017-03-28
Completion
2021-02-04

Countries

  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015832 on ClinicalTrials.gov