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

NCT04582877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-12-02

Study results available
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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

Interventions

DEVICE

FFR measurement

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

Sponsors & Collaborators

  • Zurich Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Junbo Ge, MD · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2023-11-15
Completion
2024-04-30
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582877 on ClinicalTrials.gov