Coronary Artery DiseaseSUPERIORNCT04617899
The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria
A study testing Intravascular imaging in people with Coronary Artery Disease, run by CardioNavi MedTech (Wuhan) Co., Ltd. at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intravascular imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 17 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Chaoyang District, 100029
Yong Zeng, Dr.
- Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Fengtai District, 100050
- Recruiting
Chinese PLA General Hospital
Beijing, Haidian District, 100039
Jing Jing, Dr.
Yundai Chen, Professor
- Recruiting
Peking University Third Hospital
Beijing, Haidian District
Yida Tang, Dr.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Intravascular imaging
- Keywords
- Intravascular imaging, Intravascular ultrasound, Optical coherence tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular imagingDiagnostic test
Use of imaging catheter
| Study group | Role | What they receive |
|---|---|---|
| Novasight IVUS/OCT | Experimental | A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter Receives: Diagnostic Test: Intravascular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: During the procedure
Secondary outcomes (7)
Catheter-related major adverse events
Cardiac death, myocardial infarction, blood-limited dissection
Measured: Periprocedure
Clear stent length measured by Core lab
Clear stent length is defined as the total stent length visualized within the clear image length.
Measured: During the procedure
Device Success
Successfully deliver the catheter to the target lesion and withdrawal without fracture
Measured: During the procedure
Technical Success
Successfully imaging
Measured: During the procedure
Image quality evaluated by operator
Objective and subjective assessment of image quality.
Measured: During the procedure
System reliability evaluated by operator
Objective and subjective assessment of system reliability.
Measured: During the procedure
Catheter operability evaluated by operator
Objective and subjective assessment of catheter operability.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start17 Mar 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioNavi MedTech (Wuhan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617899
- Sponsor's protocol ID
- CardioNavi
- Acronym
- SUPERIOR
- Status last verified
- May 2021
- First submitted
- 21 Oct 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the policy of the Human Genetic Resource Administration of China, the data is limited and it could not be shared currently.
Publications
Jin Q, Fu Z, Wang Y, Zeng Y, Zhang X, Ye Y, Tang Y, Xu X, Chen Y. A Multicenter Feasibility and Safety Study of a Novel Hybrid IVUS-OCT Imaging System. JACC Asia. 2025 Mar;5(3 Pt 1):396-400. doi: 10.1016/j.jacasi.2025.01.009.
PubMed 40049934
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Evaluate the Performance and Safety of the Novasight Hybrid System Using Objective Performance Criteria
- ClinicalTrials.gov ID
- NCT04617899
- Acronym / sponsor ID
- SUPERIOR / CardioNavi
- Conditions
- Coronary Artery Disease
- Keywords
- Intravascular imaging, Intravascular ultrasound, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CardioNavi MedTech (Wuhan) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novasight IVUS/OCT | Experimental | Diagnostic Test: Intravascular imagingA coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular imagingUse of imaging catheter | Diagnostic test | Novasight IVUS/OCT |
Primary outcome
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%
7 secondary outcomes
Catheter-related major adverse events
Time frame: Periprocedure
Clear stent length measured by Core lab
Time frame: During the procedure
Device Success
Time frame: During the procedure
Technical Success
Time frame: During the procedure
Image quality evaluated by operator
Time frame: During the procedure
System reliability evaluated by operator
Time frame: During the procedure
Catheter operability evaluated by operator
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 40049934Jin Q, Fu Z, Wang Y, Zeng Y, Zhang X, Ye Y, Tang Y, Xu X, Chen Y. A Multicenter Feasibility and Safety Study of a Novel Hybrid IVUS-OCT Imaging System. JACC Asia. 2025 Mar;5(3 Pt 1):396-400. doi: 10.1016/j.jacasi.2025.01.009.
- Individual participant dataSharing planned: No. According to the policy of the Human Genetic Resource Administration of China, the data is limited and it could not be shared currently.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular imaging in people with Coronary Artery Disease, run by CardioNavi MedTech (Wuhan) Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muyan Zou (0086-15564579827, zoumuyan@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clear image length measured by Core lab (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.