CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 455 enrolled
Drug / intervention
Percutaneous coronary intervention (PCI) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02328820
NCT02328820N/ACompleted
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DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements)

The University of Texas Health Science Center, Houston·interventional·Posted Dec 31, 2014·Updated Apr 6, 2021

In Brief

A clinical study evaluating Percutaneous coronary intervention (PCI) and Optimal medical therapy (OMT) for Coronary Artery Disease. Completed, enrolled 455 participants across 12 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesDenmark, Italy, Japan, Netherlands, Spain, United Kingdom
CollaboratorsAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Volcano Corporation

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 31, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2019
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.5 years ago

Interventions

Percutaneous coronary intervention (PCI)other

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

Optimal medical therapy (OMT)other

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