CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
St. Jude Medical Pressure Wire +1 moredevice
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/NCT02648230
NCT02648230N/ACompleted

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

Columbia University·interventional·Posted Jan 6, 2016·Updated Jun 14, 2019

In Brief

A clinical study evaluating St. Jude Medical Pressure Wire and ACIST Navvus Microcatheter for Ischemia and Angina. Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemia, Angina
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 6, 2016
Enrollment StartDec 1, 2015
Primary CompletionDec 8, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.5 years ago

Interventions

St. Jude Medical Pressure Wiredevice

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

ACIST Navvus Microcatheterdevice

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