The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
The VRS100 is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuang, China
Clinical Success
Defined as angiographic success (residual stenosis after stenting of \<30% with final TIMI \[Thrombolysis In Myocardial Infarction\] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization).
Time frame: 48-hrs or hospital discharge, whichever occurs first
Technical Success
Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
Time frame: 1 day
PCI Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: During procedure
Overall Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time frame: During procedure
Fluoroscopy and/or X-Ray Time
As recorded by an X-Ray System utilized during the procedure.
Time frame: During procedure
Patient Radiation Exposure - Cumulative Dose
Cumulative dose (mGy) as recored during the procedure.
Time frame: During procedure
Contrast Fluid Volume
The amount of contrast fluid used (mL) during the procedure.
Time frame: During procedure
Performance of the Experimental Device
The frequency of failures and performance evaluation
Time frame: During procedure
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