NCT02648230

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemia
• Angina

Interventions

Type	Name	Description
DEVICE	St. Jude Medical Pressure Wire	FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time
DEVICE	ACIST Navvus Microcatheter	FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-08
• Completion: 2016-12-08
• First posted: 2016-01-06
• Last updated: 2019-06-14
• Results posted: 2019-06-14

Locations

1 site across 1 country: United States