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

Primary Purpose

Coronary; Ischemic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Volcano Verrata Pressure Wire

St. Jude Medical (SJM) Aeris Pressure Wire System

About this trial

This is an interventional diagnostic trial for Coronary; Ischemic focused on measuring Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years.
Patient provides signed written informed consent before any study-specific procedure.
Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
Angiographically 40%-90% stenosis present in at least one native coronary artery.
Undergoing physiological assessment for standard clinical or diagnostic indications

Exclusion Criteria:

Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
Left main stenosis
Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
Saphenous vein graft, chronic total occlusion
Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
Currently participating in another clinical study that interferes with study results.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
High degree A-V block, sinus node disease.
Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze
Known hypersensitivity to adenosine
ST-Elevation Myocardial Infarction (STEMI) within 48 hours.

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary

Arm Description

All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion.

Outcomes

Primary Outcome Measures

Percentage Agreement Between Mean RFR and iFR Measurements

Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.

Secondary Outcome Measures

Lesion Classification (FFR≤/>0.80) by RFR

Lesion Classification (FFR≤/>0.80) by iFR

Pressure Drift of RFR

Pressure Drift of iFR

Measurement Reproducibility for RFR

Reproducibility of RFR will be tested against iFR. Reproducibility will be measured by comparing the measure of RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2 against iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2.

Measurement Reproducibility for iFR

Reproducibility of iFR will be tested against RFR. Reproducibility will be measured by comparing the measure of iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2 against RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2.

Ability to Advance to the Target Lesion and Measure RFR and iFR

Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures

Full Information

NCT ID

NCT03461705

First Posted

February 22, 2018

Last Updated

January 28, 2020

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03461705

Brief Title

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

Acronym

RFR

Official Title

Derivation and Validation of a Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

After 5 patients, realized that the standard deviation of the measurements in real life was higher than the calculated difference.

Study Start Date

October 20, 2017 (Actual)

Primary Completion Date

August 2, 2018 (Actual)

Study Completion Date

August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Fractional flow reserve (FFR) measurement by 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 in two large-scale randomized controlled trials using a non-hyperemic resting measurement, the instantaneous wave free ratio (iFR) showed non-inferiority in major adverse cardiovascular events (MACE) comparing iFR to FFR for physiological assessment of moderate coronary stenosis. FFR is calculated as the ratio of the distal coronary pressure to the aortic pressure (Pd/Pa) during maximal micro-circulatory relaxation. iFR is a diagnostic tool used to assess whether a stenosis is causing a limitation of blood flow in coronary arteries with subsequent ischemia. iFR is performed during cardiac catheterization (angiography) using invasive coronary pressure wires which are placed in the coronary arteries that are to be assessed. The iFR negates the time averaging and administration of vasodilators necessary for FFR by identifying from the resting pressure waveform a period when the native microcirculatory resistance is constant and minimized in diastole. The study is looking at the accuracy and precision of a novel adenosine-independent index of coronary artery stenosis, the resting flow reserve, against the instantaneous wave-free ratio and fractional flow reserve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary; Ischemic

Keywords

Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Volcano Verrata Pressure Wire

Other Intervention Name(s)

iFR Wire

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

St. Jude Medical (SJM) Aeris Pressure Wire System

Other Intervention Name(s)

RFR Wire

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage Agreement Between Mean RFR and iFR Measurements

Description

Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.

Time Frame

During procedure

Secondary Outcome Measure Information:

Title

Lesion Classification (FFR≤/>0.80) by RFR

Time Frame

During procedure

Title

Lesion Classification (FFR≤/>0.80) by iFR

Time Frame

During procedure

Title

Pressure Drift of RFR

Time Frame

During procedure

Title

Pressure Drift of iFR

Time Frame

During procedure

Title

Measurement Reproducibility for RFR

Description

Time Frame

During procedure

Title

Measurement Reproducibility for iFR

Description

Time Frame

During procedure

Title

Ability to Advance to the Target Lesion and Measure RFR and iFR

Description

Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures

Time Frame

During procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years. Patient provides signed written informed consent before any study-specific procedure. Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care. Angiographically 40%-90% stenosis present in at least one native coronary artery. Undergoing physiological assessment for standard clinical or diagnostic indications Exclusion Criteria: Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). Left main stenosis Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease. Saphenous vein graft, chronic total occlusion Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump Currently participating in another clinical study that interferes with study results. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. High degree A-V block, sinus node disease. Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze Known hypersensitivity to adenosine ST-Elevation Myocardial Infarction (STEMI) within 48 hours.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajay Kirtane, MD

Organizational Affiliation

CUMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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