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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Intravascular imaging

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muyan Zou; Phone Number: 0086-15564579827; Email: zoumuyan@qq.com

Study Locations

• China
  • Chaoyang District
    • Beijing, Chaoyang District, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Yong Zeng, Dr.
  • Fengtai District
    • Beijing, Fengtai District, China, 100050
      • Not yet recruiting
      • Beijing Tiantan Hospital, Capital Medical University
  • Haidian District
    • Beijing, Haidian District, China, 100039
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Jing Jing, Dr.
      • Principal Investigator: Yundai Chen, Professor
    • Beijing, Haidian District, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Yida Tang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Novasight IVUS/OCT; A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter	Diagnostic test: Intravascular imaging; Use of imaging catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CardioNavi MedTech (Wuhan) Co., Ltd.
• Collaborators: Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Intravascular ultrasound; Intravascular imaging
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CardioNavi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the policy of the Human Genetic Resource Administration of China, the data is limited and it could not be shared currently.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No