The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Intravascular imaging


Participation Criteria
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Eligibility Criteria
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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: The reference diameter of target vessel is less than 2.5 mm. The target lesion involves myocardial bridge. The target lesion is in the left main coronary artery or the damage is observed in the ostium. Severe calcification in the target vessel. Severe tortuosity in the target vessel. Multiple contiguous stent implantation in the target vessel. Subject has coronary artery spasm. In-stent restenosis. Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novasight IVUS/OCT<br>A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter | Diagnostic Test: Intravascular imaging<br>* Use of imaging catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clear image length measured by Core lab | 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% | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related major adverse events | Cardiac death, myocardial infarction, blood-limited dissection | Periprocedure | 
| Clear stent length measured by Core lab | Clear stent length is defined as the total stent length visualized within the clear image length. | During the procedure | 
| Device Success | Successfully deliver the catheter to the target lesion and withdrawal without fracture | During the procedure | 
| Technical Success | Successfully imaging | During the procedure | 
| Image quality evaluated by operator | Objective and subjective assessment of image quality. | During the procedure | 
| System reliability evaluated by operator | Objective and subjective assessment of system reliability. | During the procedure | 
| Catheter operability evaluated by operator | Objective and subjective assessment of catheter operability. | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular imaging, Intravascular ultrasound, Optical coherence tomography