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

Zurich Medical

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Device: FFR measurement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04582877

WXYL-LC-2018001

Details and patient eligibility

About

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.

Full description

The objective of the 'Pressure guidewire system multi-center, prospective, single-subject design clinical trial' is to evaluate the effectiveness and safety of Zurich Medical's pressure guidewire system (including guidewire with high-fidelity sensors and a unique paired portable display unit), which is used to measure the coronary artery blood fractional flow reserve (FFR) to diagnose coronary artery disease, and to direct a catheter through a blood vessel. This clinical trial uses a multi-center, prospective, single-subject design trial method, using St. Jude Medical's pressure guidewire and Analyzer Express as a control device. The subjects who met the criteria for this study will be registered with the central registration system after enrollment. 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). Both articles are used within the same participant and the FFR values are statistically compared with each other. The subject's FFR of coronary artery stenosis will first be measured using investigational device and recorded, and then measured using control device and recorded. The safety follow-up period is 48 hours.

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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;
• There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

FFR Measurement in Intermediate-Grade Coronary Stenosis

Other group

Description:

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).

Treatment:

Device: FFR measurement