Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial

NCT04582877 | Completed Results FDA Device

• 1 other identifier: WXYL-LC-2018001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device

  Diagnostic consistency rate: When the measurement of control device is positive (FFRPW ≤ 0.80) or negative (FFRPW \> 0.80), investigational device is also positive (FFRWS ≤ 0.80) or negative (FFRWS \> 0.80). Each subject will be considered a research unit (for patients with multiple lesions, the method of converting the results of multiple lesions into patient level is defined in the statistical analysis plan), and the coronary artery FFRPW measured by control device will be taken as reference. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

Secondary Outcomes (9)

• The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

• The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

• Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

• Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

• Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease

  Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.

Study Arms (1)

FFR Measurement in Intermediate-Grade Coronary Stenosis

OTHER

Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).

Device: FFR measurement

Interventions

FFR measurement DEVICE

FFR is measured sequentially with the test article and the predicate device.

FFR Measurement in Intermediate-Grade Coronary Stenosis

Eligibility Criteria

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

You may qualify if:

• Age 18 to 75 years old, gender-unrestricted, non-pregnant female;
• Understand and be willing to sign an informed consent form;
• Diagnosed with coronary heart disease;
• Intrusive ICA and FFR measurement are needed;
• Visual coronary angiography showed at least one moderate stenosis lesion (diameter stenosis of 30% - 70%) on the coronary artery with diameter ≥ 2.5mm

You may not qualify if:

• Patient who do not understand or are unwilling to sign an informed consent form;
• Has a history of myocardial infarction;
• Patient with other serious diseases are not suitable for clinical trials, such as a complex congenital heart disease history, severe heart failure(NYHA cardiac function level IV), long QT syndrome, severe hypertension, Severe asthma, severe chronic obstructive pulmonary disease, liver and kidney dysfunction and other serious infections and critical illnesses;
• Coronary intervention surgery contraindications;
• Patient with ATP contraindications (ATP contraindications: sinus syndrome, sinus insufficiency and the elderly with cautious use or no use);
• The clinical manifestations of patients show acute instability, including acute chest pain (sudden appearance), cardiogenic shock, unstable blood pressure (systolic pressure less than 90mmHg), severe congestive heart failure or acute pulmonary edema;
• The angiography shown or suspect of thrombosis;
• The angiography shown or suspect of dissection;
• Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion;

Sponsors & Collaborators

• Zurich Medical Inc.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Charles Chan
• Organization: Zurich Medical

cchan@zurichmed.com

(612) 889-9412

Study Officials

• Junbo Ge, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: September 17, 2020
• First Posted: October 12, 2020
• Study Start: September 23, 2020
• Primary Completion: November 15, 2023
• Study Completion: April 30, 2024
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)