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Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve

NCT03461705 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-02-07

Study results available
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Summary

This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. There are no follow up visits required so participation in this study will end when subjects are discharged from the hospital.The study will be comparing the resting flow reserve against the instantaneous wave-free ratio (iFR) and fractional flow reserve. All these tests offer a way to image a legion and determine if it is suitable to be treated. FFR measures the pressure differences across (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed in the arteries of the heart that are to be assessed and the Resting flow reserve looks at the maximum increase in blood flow through the coronary arteries above the normal resting volume.

Conditions

  • Coronary; Ischemic

Interventions

DEVICE

Volcano Verrata Pressure Wire

Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014". and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.

DEVICE

St. Jude Medical (SJM) Aeris Pressure Wire System

The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.

Sponsors & Collaborators

Principal Investigators

  • Ajay Kirtane, MD · CUMC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2018-08-02
Completion
2018-08-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461705 on ClinicalTrials.gov