PRECISION GRX Post-Market Study - Japan

Study Overview
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Brief Summary
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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 in the first 231 patients treated with the CorPath device in Japan.

Detailed Description
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This is a single-arm, open-label, multi-center patient registry in Japan 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.

Official Title
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A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Robotic-assisted PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 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, unless the EC has waived informed consent. Exclusion Criteria: Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic PCI<br>All subjects treated with CorPath GRX during the PCI procedure. | Device: Robotic-assisted PCI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual stenosis in the lesion(s) treated | Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse cardiac events (MACE) as assessed by the Angiographic Core Laboratory (ACL). | Through end of subject's participation in the study, an average of up to 3 days. | 
| Technical Success | 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. | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) | MACE that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath GRX System. | Through end of subject's participation in the study, an average of up to 3 days. | 
| Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | During procedure | 
| PCI Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | During procedure | 
| IVUS/OCT/IVUS-OCT Time (if used) | Defined as the total time measured from insertion of the imaging catheter [Intravascular Ultrasound (IVUS), Optical Coherence Tomography (OCT) or integrated IVUS-OCT (IVUS-OCT)] until the removal of the imaging catheter. | During procedure | 
| Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. | During procedure | 
| Patient Radiation Exposure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure. | During procedure | 
| Operator Radiation Exposure | Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure. | During procedure |