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

NCT ID: NCT04098172

Last Updated: 2021-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-03-11

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pressure Guidewire

Intervention Type DEVICE

Fractional Flow Reserve measurement

Interventions

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Pressure Guidewire

Fractional Flow Reserve measurement

Intervention Type DEVICE

Eligibility Criteria

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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


Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography

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


CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ning Guo, Dr

Role: PRINCIPAL_INVESTIGATOR

The First Afflilited Hospital of Xi,an Jiaotong University

Locations

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The First Affilited Hospital of Xi,an Jiaotong University

Xi'an, Shaanxi, China

Site Status

The General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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S2434

Identifier Type: -

Identifier Source: org_study_id