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

A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Pressure Guidewire

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affilited Hospital of Xi,an Jiaotong University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • The General Hospital of Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Pressure Guidewire; Fractional Flow Reserve measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Ning Guo, Dr, The First Afflilited Hospital of Xi,an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: February 3, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: S2434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes