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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements


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 CertusĀ® 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pressure Guidewire
Fractional Flow Reserve measurement

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

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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