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To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
Condition or disease
Coronary Artery Disease
Device: Robotic-assisted PCI
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
The CorPath GRX 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 [ Time Frame: Discharge or 72 hours post intervention, whichever comes first. ]
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
Technical Success [ Time Frame: Procedure ]
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
Secondary Outcome Measures :
Overall Procedure Time [ Time Frame: Procedure ]
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
PCI Procedure Time [ Time Frame: Procedure ]
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Fluoroscopy Time [ Time Frame: Procedure ]
Total Fluoroscopy Time during procedure will be captured.
Patient Radiation Exposure [ Time Frame: Procedure ]
DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with coronary artery disease and with a clinical indication for PCI.
Candidates will be included in the study only if all of the following conditions are met:
Age ≥18 years;
Patients with coronary artery disease with clinical indication for PCI;
Patient deemed appropriate for robotic-assisted PCI; and
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Candidates will be excluded from the study if any of the following conditions are present:
Failure/inability/unwillingness to provide informed consent; or
The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.