Vascular Interventional Robotic System
DeviceThe cerebral angiography will be performed by using the vascular interventional robotic system
NCT Number: NCT07182188
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The cerebral angiography will be performed by using the vascular interventional robotic system
Time frame: At the end of surgery
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 day after surgery
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 end of surgery
Record and compare the duration of each surgical procedure.
Time frame: At the end of surgery
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
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
Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure.
Time frame: At the end of surgery
Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure.
Time frame: At the end of surgery
Record and compare the absorbed dose of radiation received by the participant during each surgical procedure.
Time frame: At the end of surgery
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
Document the frequence where robotic operations transition to manual operations due to certain force majeure events.
Time frame: At the end of Surgery
Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery.
Peking Union Medical College Hospital
Other
Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.