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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Use of imaging catheter
Beijing Anzhen Hospital, Capital Medical University
Beijing, Chaoyang District, China
RECRUITINGBeijing Tiantan Hospital, Capital Medical University
Beijing, Fengtai District, China
NOT_YET_RECRUITINGChinese PLA General Hospital
Beijing, Haidian District, China
RECRUITINGClear 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%
Time frame: During the procedure
Catheter-related major adverse events
Cardiac death, myocardial infarction, blood-limited dissection
Time frame: Periprocedure
Clear stent length measured by Core lab
Clear stent length is defined as the total stent length visualized within the clear image length.
Time frame: During the procedure
Device Success
Successfully deliver the catheter to the target lesion and withdrawal without fracture
Time frame: During the procedure
Technical Success
Successfully imaging
Time frame: During the procedure
Image quality evaluated by operator
Objective and subjective assessment of image quality.
Time frame: During the procedure
System reliability evaluated by operator
Objective and subjective assessment of system reliability.
Time frame: During the procedure
Catheter operability evaluated by operator
Objective and subjective assessment of catheter operability.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University Third Hospital
Beijing, Haidian District, China
RECRUITINGTime frame: During the procedure