Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses — DEFINE-FLOW  

Coronary Artery Disease Clinical Trial

Official title: DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements)

Status Completed

Clinical Trial 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).

Clinical Trial Description

Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR>=2.0 can be reasonably treated with medical therapy despite a reduced FFR<=0.8. ;

Related Conditions & MeSH terms

• Coronary Artery Disease

• NCT number: NCT02328820
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: April 2021