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

Coronary Artery Disease Clinical Trial

— SUPERIOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617899
• Other study ID #: CardioNavi
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: CardioNavi MedTech (Wuhan) Co., Ltd.
• Contact: Muyan Zou
• Phone: 0086-15564579827
• Email: zoumuyan[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Intravascular imaging
Use of imaging catheter

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Chaoyang District
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Fengtai District
China	Chinese PLA General Hospital	Beijing	Haidian District
China	Peking University Third Hospital	Beijing	Haidian District

Sponsors (2)

Lead Sponsor	Collaborator
CardioNavi MedTech (Wuhan) Co., Ltd.	Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Catheter-related major adverse events	Cardiac death, myocardial infarction, blood-limited dissection	Periprocedure
Secondary	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
Secondary	Device Success	Successfully deliver the catheter to the target lesion and withdrawal without fracture	During the procedure
Secondary	Technical Success	Successfully imaging	During the procedure
Secondary	Image quality evaluated by operator	Objective and subjective assessment of image quality.	During the procedure
Secondary	System reliability evaluated by operator	Objective and subjective assessment of system reliability.	During the procedure
Secondary	Catheter operability evaluated by operator	Objective and subjective assessment of catheter operability.	During the procedure