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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098172
• Other study ID #: S2434
• Status: Completed
• Phase: N/A
• 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
• 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 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.

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

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 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