Clinical trial NCT04617899: The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria
Official title: The Study to Evaluate the Performance and Safety of the Novasight Hybrid System Using Objective Performance Criteria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Intravascular imaging
Intravascular ultrasound
Optical coherence tomography
Lead sponsor: CardioNavi MedTech (Wuhan) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd
First posted: 2020-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clear image length measured by Core lab
timeFrame: During the procedure
Secondary outcomes:
measure: Catheter-related major adverse events
timeFrame: Periprocedure
measure: Clear stent length measured by Core lab
timeFrame: During the procedure
measure: Device Success
timeFrame: During the procedure
measure: Technical Success
timeFrame: During the procedure
measure: Image quality evaluated by operator
timeFrame: During the procedure
measure: System reliability evaluated by operator
timeFrame: During the procedure
measure: Catheter operability evaluated by operator
timeFrame: During the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Chaoyang District
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Fengtai District
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Haidian District
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian District
Study officials:
References: