The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
Doctors perform traditional percutaneous coronary intervention
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, Guandong, China
Linfen Central Hospital
Shanxi, Linfen, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
Clinical Success
Immediate postoperative angiography showed residual stenosis \< 30% and TIMI blood flow fraction Level 3.
Time frame: Immediate postoperative angiography
Clinical Success
No MACE occurred in hospital.
Time frame: Discharge or 48 hours post intervention, whichever comes first
Technical success rate
1. PCI was assisted by the Pan-vascular Interventional Robotic System. 2. No unplanned complete conversion to artificial surgery occurred due to the inability to complete the delivery of the guide wire or balloon/stent catheter through the vessel with the test instrument as intended, or due to insufficient guide catheter support.
Time frame: Procedure
Radiation Exposure
Patient and Main operator radiation exposure dose recorded by portable radiation
Time frame: Procedure
Fluoroscopy Time
Total Fluoroscopy Time during procedure will be captured.
Time frame: Procedure
Contrast agent dosage
The total amount of contrast agent used during the whole procedure.
Time frame: Procedure
Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time frame: Procedure
PCI time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: Procedure
the Pan-vascular Interventional Robotic Systemt performance evaluation
The performance of the product was subjectively evaluated by the surgeon.
Time frame: After the operation
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