Trial Outcomes & Findings for Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR (NCT NCT04098172)

Last Updated: 2021-11-01

Results Overview

All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires Certus®. Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.75-0.80 is generally considered to be associated with myocardial ischemia (MI). Agreement between the method of measurement will be confirmed if both conditions are met: The mean paired difference is within +/- 0.005

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

during procedure, 1 hour

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pressure Guidewire Test Subject Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. Pressure Guidewire: Fractional Flow Reserve measurement
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pressure Guidewire Test Subject n=39 Participants Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. Pressure Guidewire: Fractional Flow Reserve measurement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Chinese han nationality	39 participants n=5 Participants
Region of Enrollment China	39 participants n=5 Participants
Weight	70.9 Kg STANDARD_DEVIATION 12.7 • n=5 Participants
Medical History history of hypertension	24 Participants n=5 Participants
Medical History history of diabetes	9 Participants n=5 Participants
Medical History history of Cerebrovascular disease	3 Participants n=5 Participants
Medical History history of Coronary heart disease	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: during procedure, 1 hour

Population: Pressure guide wire

Outcome measures

Outcome measures
Measure	Comet Pressure Guidewire Test Subject n=39 Participants Stable patients with suspected or known Coronary Atherosclerotic Disease (CAD), who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. Pressure Guidewire: Fractional Flow Reserve measurement	Certus Pressure Guidewire Test Subject n=39 Participants Stable patients with suspected or known Coronary Atherosclerotic Disease (CAD), who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. Pressure Guidewire: Fractional Flow Reserve measurement
Fractional Flow Reserve (FFR)	0.862 Ratio Interval 0.841 to 0.883	0.863 Ratio Interval 0.842 to 0.884

Adverse Events

Pressure Guidewire Test Subject

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Pressure Guidewire Test Subject n=39 participants at risk Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study. Pressure Guidewire: Fractional Flow Reserve measurement
Vascular disorders Subclavian artery stenosis	2.6% 1/39 • Number of events 39 • The adverse event data were collected from subject procedure to subjects were discharged from hospital in 1 week.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ning Guo

First Affiliated Hospital of Xi 'an Jiaotong University

Phone: 13991229101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place