Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: Pressure Guidewire

• Registration Number: NCT04098172
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2019-02-03
• Study Start: 2019-09-03
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-23
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Results First Submitted: 2020-12-08
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-11
• Results First Posted: 2021-06-07
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pressure Guidewire test subject	Pressure Guidewire	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

The First Affilited Hospital of Xi,an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

The General Hospital of Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China