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PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements — PERFORM  

Ischemia Clinical Trial

Official title:
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of cORonary Fractional Flow Reserve Measurements

Clinical Trial Summary

The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.

Clinical Trial Description

Fractional flow reserve (FFR) measurement by pressure wire (PW) under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently a microcatheter (MC)-based sensor measurement of fractional flow reserve has been introduced. Small scale in-vivo comparisons have been performed suggesting the utility of this approach to measure FFR,but these data are limited and have not been independently validated. This non-randomized, prospective study is designed to evaluate the accuracy of MC-based FFR measurement to the PW standard in lesions subjected to FFR assessment in routine clinical practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02648230
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase N/A
Start date December 2015
Completion date December 8, 2016
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