Pan-vascular interventional robotic system
DevicePan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
NCT Number: NCT06502938
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Beijing Anzhen 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
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
Time frame: Immediate postoperative angiography
Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3.
Time frame: Discharge or 48 hours post intervention, whichever comes first
No MACE occurred in hospital.
Time frame: Procedure
Time frame: Procedure
Patient and Main operator radiation exposure dose recorded by portable radiation
Time frame: Procedure
Total Fluoroscopy Time during procedure will be captured.
Time frame: Procedure
The total amount of contrast agent used during the whole procedure.
Time frame: Procedure
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time frame: Procedure
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: After the operation
The performance of the product was subjectively evaluated by the surgeon.
Contact information is provided by the study sponsor or research team.
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Industry
To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
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