The Study to Evaluate the Performance and Safety of the Novasight Hybrid System Using Objective Performance Criteria

CardioNavi MedTech (Wuhan) Co., Ltd.4 sites in 1 country120 target enrollmentMarch 17, 2021

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: CardioNavi MedTech (Wuhan) Co., Ltd.
Enrollment: 120
Locations: 4
Primary Endpoint: Clear image length measured by Core lab
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.

Registry

clinicaltrials.gov

Start Date

March 17, 2021

End Date

December 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CardioNavi MedTech (Wuhan) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be at least 18 years of age and less than 85 years of age.
•Subject must be informed and sign a written consent
•Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.

Exclusion Criteria

•Women who are pregnant or cannot eliminate the possibility to be pregnant.
•Estimated creatinine clearance \<30 ml/min/1.73 m2 using Cockcroft equation.
•LVEF(Left ventricular ejection fraction) \< 35% by the most recent imaging test within 7 days prior to procedure.
•Unstable ventricular arrhythmias.
•High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.
•Known contraindication to anticoagulants and antiplatelets therapy.
•Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.
•Any intervention for not target vessel within 48 hours after the study procedure.
•Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.
•Angiographic exclusion criteria:

Outcomes

Primary Outcomes

Clear image length measured by Core lab

Time Frame: During the procedure

The clear image length is transformed from the clear image frame, and the ratio of the clear image can be calculated by Clear image length / Full image length \* 100%