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

NCT03461705 | Terminated Results FDA Device

• 1 other identifier: AAAR4732
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary; Ischemic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During procedure

Secondary Outcomes (7)

• 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

Study Arms (1)

Primary

EXPERIMENTAL

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.

Device: Volcano Verrata Pressure Wire; Device: St. Jude Medical (SJM) Aeris Pressure Wire System

Interventions

Volcano Verrata Pressure Wire DEVICE

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.

Also known as: iFR Wire

Primary

St. Jude Medical (SJM) Aeris Pressure Wire System DEVICE

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

Also known as: RFR Wire

Primary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ischemia; Coronary Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical

Limitations and Caveats

The standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques so study halted early and data was not collected and analyzed.

Results Point of Contact

• Title: Ajay Kirtane, MD, SM
• Organization: Columbia University

akirtane@columbia.edu

212-305-7060

Study Officials

• Ajay Kirtane, MD

  CUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 12, 2018
• Study Start: October 20, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: February 7, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)