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A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure Guidewire test subject | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure Guidewire | Device | Fractional Flow Reserve measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during procedure, 1 hour |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography
General Exclusion Criteria:
Angiographic Exclusion Criteria:
CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction
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| Name | Affiliation | Role |
|---|---|---|
| Ning Guo, Dr | The First Afflilited Hospital of Xi,an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affilited Hospital of Xi,an Jiaotong University | Xi'an | Shaanxi | 710061 | China | ||
| The General Hospital of Tianjin Medical University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Pressure guide wire | Posted | Geometric Mean | 95% Confidence Interval | Ratio | during procedure, 1 hour |
|
The adverse event data were collected from subject procedure to subjects were discharged from hospital in 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subclavian artery stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment | The SAE was not related to the study device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ning Guo | First Affiliated Hospital of Xi 'an Jiaotong University | 13991229101 | +86 | drnguo@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2019 | Dec 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 25, 2020 | Dec 7, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Tianjin |
| Tianjin Municipality |
| 300052 |
| China |
| Participants |
| No |
|
| Age, Continuous | Geometric Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Geometric Mean | Standard Deviation | Kg |
|
| Medical History | Count of Participants | Participants |
|
| OG001 | Certus Pressure Guidewire Test Subject | 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 |
|
|
| 1 |
| 39 |
| 1 |
| 39 |
| 0 |
| 39 |
|
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