ACHIEVE GRX Registry

Study Overview
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Brief Summary
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This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.

Detailed Description
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This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.

Official Title
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A Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Peripheral Vascular Interventions

Conditions
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Peripheral Arterial Disease, Peripheral Vascular Diseases, Renal Artery Disease, Carotid Artery Diseases

Intervention / Treatment
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* Device: Procedure/Surgery: Robotic-PVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Subject has a clinical indication for Peripheral Vascular Intervention (PVI). Subject is deemed appropriate for robotic-assisted PVI. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure. Exclusion Criteria: Failure/inability/unwillingness to provide informed consent. The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI. Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Subjects with a clinical indication for PVI<br>Subjects with a clinical indication for Peripheral Vascular Intervention (PVI). | Device: Procedure/Surgery: Robotic-PVI<br>* Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy. | Procedure | 
| Clinical Success | <30% residual stenosis in all CorPath System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse event (SAE). | Within 24 hours of the procedure or hospital discharge, whichever occurs first. | 
| Safety | A composite of intra- and peri-procedural events, including target vessel rupture, clinically significant perforation or dissection, and distal embolization. | Within 24 hours of the procedure or hospital discharge, whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVI Procedure Time | Defined as the time measured from the insertion of the guiding sheath until the removal of the guiding sheath. | Procedure | 
| Manual Time | Defined as the total amount of time the procedure is completed using a manual technique. | Procedure | 
| Robotic Time | Defined as the total amount of time the procedure is completed robotically from the robotic cock-pit. | Procedure | 
| Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. | Procedure | 
| Operator Radiation Exposure | Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure. | Procedure | 
| Staff Radiation Exposure | Cumulative dose the staff receives as recorded from an electronic pocket dosimeter during the procedure. | Procedure | 
| Patient Radiation Exposure | DAP (dose-area-product) and AK (air kerma) as recorded during the procedure. | Procedure | 
| Contrast Fluid Volume | Total volume of contrast (mL) used during the procedure. | Procedure |