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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582877
• Other study ID #: WXYL-LC-2018001
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Zurich Medical Inc.
• Contact: Charles Chan
• Phone: 651-571-0020
• Email: cchan[@]zurichmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

Device:
• FFR measurement
FFR is measured sequentially with the test article and the predicate device.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zurich Medical Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared FFR Measurement Between Test Article and Predicate Article		Acute