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

NCT04098172 | Completed Results FDA Device

• 1 other identifier: S2434
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pressure Guidewire test subject

EXPERIMENTAL

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

Interventions

Pressure Guidewire DEVICE

Fractional Flow Reserve measurement

Pressure Guidewire test subject

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be at least 18 years old and less than or equal to 75 years of age
• Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
• 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

You may not qualify if:

• Patients unable to provide informed consent
• Patients in pregnant state
• Known renal insufficiency or failure (serum creatinine level of \> 2.5 mg/dL, or on dialysis)
• Allergy to the contrast
• Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
• Spastic bronchial asthma
• ST elevation coronary syndrome
• Hemodynamic instability
• Contraindication to nitroglycerin or ATP
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

The First Affilited Hospital of Xi,an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

The General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Ning Guo
• Organization: First Affiliated Hospital of Xi 'an Jiaotong University

drnguo@gmail.com

13991229101

Study Officials

• Ning Guo, Dr

  The First Afflilited Hospital of Xi,an Jiaotong University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: September 23, 2019
• Study Start: September 3, 2019
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: November 1, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)