Status:
COMPLETED
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
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 stab...
Eligibility Criteria
Inclusion
- General
- Patient must be at least 18 years old and less than or equal to 75 years of age
- Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
- 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
- Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography
- General
Exclusion
- Patients unable to provide informed consent
- Patients in pregnant state
- Known renal insufficiency or failure (serum creatinine level of \> 2.5 mg/dL, or on dialysis)
- Allergy to the contrast
- Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
- Spastic bronchial asthma
- ST elevation coronary syndrome
- Hemodynamic instability
- Contraindication to nitroglycerin or ATP
- Current participation in another investigational drug or device clinical study that may affect the FFR measurements
- Angiographic
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04098172
Start Date
September 3 2019
End Date
March 11 2020
Last Update
November 1 2021
Active Locations (2)
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1
The First Affilited Hospital of Xi,an Jiaotong University
Xi'an, Shaanxi, China, 710061
2
The General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300052