NAVIGATE GRX Study

Study Overview
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Brief Summary
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The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.

Detailed Description
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This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.

Official Title
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A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)
* Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or nonpregnant female aged ≥ 20 years. Patients with coronary artery disease with clinical indication for Percutaneous Coronary Intervention (PCI). The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Failure/inability/unwillingness to provide informed consent. In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics. Acute STEMI within 72 hours pre-procedure.

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 |
| --- | --- |
| Intervention<br>CorPath GRX with technIQ automated movements enabled (technIQ ON) | Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)<br>* The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.<br>|
| Control<br>CorPath GRX with technIQ automated movements disabled (technIQ OFF). | Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).<br>* The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Clinical and Angiographic Complications (MCAC) | The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group. | 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. | 
| Technical Success | Residual stenosis of <30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion. | During the Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCI procedure time | Time between insertion of guide catheter and final removal of guide catheter. | During the Procedure | 
| Procedure success | The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group. | 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. | 
| Major adverse cardiovascular events (MACE), | Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR). | 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first. | 
| Major angiographic complications | Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F). | During the Procedure | 
| Serious Adverse Events (SAE) | All Serious Adverse Events (SAEs) from the start of the CorPath GRX PCI procedure through 72 hours postprocedure or hospital discharge (whichever occurs) first will be summarized | Procedure through 72 hours postprocedure or hospital discharge (whichever occurs) | 
| Guidewire Wiring Time | The time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion. | During the Procedure | 
| Fluoroscopy Time to Cross Lesion | The fluoroscopy time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion. | During the Procedure | 
| Contrast Used to Cross Lesion | The amount of contrast (in ml) required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion. | During the Procedure | 
| Total Procedural Time | The time from the start of the sheath insertion to complete removal of the final guide catheter. | During the Procedure | 
| Total Fluoroscopy Time | The total fluoroscopy time during the procedure as recorded by an Imaging System. | During the Procedure | 
| Subject Radiation Exposure | Dose-area-product (DAP) as recorded during the procedure | During the Procedure | 
| Subject Radiation Dose | air kerma (AK) as recorded during the procedure. | During the Procedure | 
| Contrast Fluid Volume | The total contrast volume used during the procedure. | During the Procedure | 
| Planned Manual Conversion (PMC) | Planned manual conversion (PMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was prespecified in the procedural plan (e.g., to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform, such as intravascular ultrasound or atherectomy devices). This will be assessed by a questionnaire. | During the Procedure | 
| Unplanned Manual Conversion (UMC) | Unplanned manual conversion (UMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was not prespecified in the procedural plan, and that was due to inability to navigate to the target lesion as intended, cross the target lesion as intended, treat the target lesion as intended, retract the CorPath GRX system as intended, or other CorPath system device malfunction; or any clinical condition that requires rapid medical intervention. This will be assessed by a questionnaire. | During the Procedure | 
| Partial Manual Assistance (PMA) | Partial manual assistance (PMA) is the use of manual techniques that were not prespecified in the procedural plan and do not meet the definition of unplanned manual conversion (e.g., unplanned use of manual techniques to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform). These will be assessed by a questionnaire. | During the Procedure | 
| Device Malfunction | The device malfunction will report the inadequacy of the medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. Investigators are instructed to report all device deficiencies and device malfunctions using the device malfunction form in the EDC. | During the Procedure |