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Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses

NCT02328820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2021-04-06

No results posted yet for this study

Summary

This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).

Conditions

Interventions

OTHER

Percutaneous coronary intervention (PCI)

For lesions with both FFR\<=0.8 and CFR\<2.0

OTHER

Optimal medical therapy (OMT)

For lesions with FFR\>0.8 or CFR\>=2.0 or both

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Volcano Corporation

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Nils Johnson, MD · University of Texas Medical School at Houston

  • Jan J Piek, MD, PhD · Academic Medical Center (AMC), Amsterdam

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-11-30
Completion
2021-04-30

Countries

  • Denmark
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02328820 on ClinicalTrials.gov