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

Not Applicable

Terminated

• Conditions: Coronary; Ischemic
• Interventions: Device: Volcano Verrata Pressure Wire; Device: St. Jude Medical (SJM) Aeris Pressure Wire System

• Registration Number: NCT03461705
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Results First Submitted: 2019-06-26
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-07
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary	St. Jude Medical (SJM) Aeris Pressure Wire System	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.
Primary	Volcano Verrata Pressure Wire	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.

Primary Outcome Measures

Name	Time	Method
Percentage Agreement Between Mean RFR and iFR Measurements	During procedure	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

Name	Time	Method
Lesion Classification (FFR≤/>0.80) by RFR	During procedure
Lesion Classification (FFR≤/>0.80) by iFR	During procedure
Pressure Drift of RFR	During procedure
Pressure Drift of iFR	During procedure
Measurement Reproducibility for RFR	During procedure	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.
Ability to Advance to the Target Lesion and Measure RFR and iFR	During procedure	Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures
Measurement Reproducibility for iFR	During procedure	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.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States