Cardiovascular Diseases Clinical Trial
Official title:
A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients
NCT number | NCT04098172 |
Other study ID # | S2434 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 3, 2019 |
Est. completion date | March 11, 2020 |
Verified date | May 2021 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
Status | Completed |
Enrollment | 39 |
Est. completion date | March 11, 2020 |
Est. primary completion date | March 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 Exclusion Criteria: CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction |
Country | Name | City | State |
---|---|---|---|
China | The General Hospital of Tianjin Medical University | Tianjin | Tianjin |
China | The First Affilited Hospital of Xi,an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional Flow Reserve (FFR) | All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires CertusĀ®. 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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