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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Intravascular imaging

• Registration Number: NCT04617899
• Lead Sponsor: CardioNavi MedTech (Wuhan) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-03-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Angiographic exclusion criteria:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novasight IVUS/OCT	Intravascular imaging	A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter

Primary Outcome Measures

Name	Time	Method
Clear image length measured by Core lab	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%

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Fengtai District, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Chaoyang District, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Haidian District, China

Peking University Third Hospital; 🇨🇳 Beijing, Haidian District, China