The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (PCI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The 5G Tele-Robotic-Assisted VRS100 system 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.
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 hours 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
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