This study aims to conduct a post-market, multicenter clinical trial utilizing an interventional robotic system for cerebral angiography. By comparing it with traditional angiography procedures, the study will systematically evaluate the efficacy and safety of robot-assisted angiography in real clinical settings. Researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, complication rate, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
660
The cerebral angiography will be performed by using the vascular interventional robotic system
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Angiography Success Rate
Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way.
Time frame: At the end of surgery
Complication Rate
Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc.
Time frame: At the day after surgery
Operation Time
Record and compare the duration of each surgical procedure.
Time frame: At the end of surgery
Super-selective Success Rate
Assessing the success rate of the surgeon in performing super-selective catheterization of each cerebral vessels through the operation of vascular interventional robotic system or manual way.
Time frame: At the end of surgery
Super-selective Catheterization Time for Vessels
Calculate and compare the average time taken for surgeon to perform super-selective catheterization for each target vessel during each surgical procedure.
Time frame: At the end of surgery
Digital Subtraction Angiography (DSA) Fluoroscopy Time
Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure.
Time frame: At the end of surgery
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Primary Operator Radiation Absorbed Dose
Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure.
Time frame: At the end of surgery
Participant Radiation Absorbed Dose
Record and compare the absorbed dose of radiation received by the participant during each surgical procedure.
Time frame: At the end of surgery
Vascular Interventional Robotic System Performance Evaluation
The surgical physician rate a score (0-10) after the surgery to subjectively evaluate the performance of the vascular interventional robotic system during the angiographic examination procedure.
Time frame: At the end of surgery
Frequence of robotic operations transition to manual operations
Document the frequence where robotic operations transition to manual operations due to certain force majeure events.
Time frame: At the end of surgery
Operation Preparation Time
Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery.
Time frame: At the end of Surgery