Cardiovascular Diseases
Conditions
Brief summary
A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
Detailed description
The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.
Interventions
DEVICEPressure Guidewire
Fractional Flow Reserve measurement
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Patient must be at least 18 years old and less than or equal to 75 years of age 2. Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure 3. Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment Angiographic Inclusion Criteria: Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography General
Exclusion criteria
1. Patients unable to provide informed consent 2. Patients in pregnant state 3. Known renal insufficiency or failure (serum creatinine level of \> 2.5 mg/dL, or on dialysis) 4. Allergy to the contrast 5. Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia 6. Spastic bronchial asthma 7. ST elevation coronary syndrome 8. Hemodynamic instability 9. Contraindication to nitroglycerin or ATP 10. Current participation in another investigational drug or device clinical study that may affect the FFR measurements Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional Flow Reserve (FFR) | during procedure, 1 hour | 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Pressure Guidewire Test Subject |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 58.6 years STANDARD_DEVIATION 9.2 |
| Medical History history of Cerebrovascular disease | 3 Participants |
| Medical History history of Coronary heart disease | 37 Participants |
| Medical History history of diabetes | 9 Participants |
| Medical History history of hypertension | 24 Participants |
| Race/Ethnicity, Customized Chinese han nationality | 39 participants |
| Region of Enrollment China | 39 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 28 Participants |
| Weight | 70.9 Kg STANDARD_DEVIATION 12.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
Primary
Fractional Flow Reserve (FFR)
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
Time frame: during procedure, 1 hour
Population: Pressure guide wire
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Comet Pressure Guidewire Test Subject | Fractional Flow Reserve (FFR) | 0.862 Ratio |
| Certus Pressure Guidewire Test Subject | Fractional Flow Reserve (FFR) | 0.863 Ratio |