Coronary Artery Disease
Conditions
Keywords
Intravascular imaging, Intravascular ultrasound, Optical coherence tomography
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.
Interventions
DIAGNOSTIC_TESTIntravascular imaging
Use of imaging catheter
Sponsors
Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd
CardioNavi MedTech (Wuhan) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| System reliability evaluated by operator | During the procedure | Objective and subjective assessment of system reliability. |
| Image quality evaluated by operator | During the procedure | Objective and subjective assessment of image quality. |
| Catheter operability evaluated by operator | During the procedure | Objective and subjective assessment of catheter operability. |
| Technical Success | During the procedure | Successfully imaging |
Countries
China
Contacts
Primary ContactMuyan Zou
Outcome results
None listed