Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.

Detailed Description
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This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.

Official Title
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CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Robotic-assisted peripheral vascular intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria At least 18 years of age; Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent. Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure. Exclusion Criteria: General Exclusion Criteria If any of the following criteria are met, the subject cannot be enrolled in this study: Failure/inability/unwillingness to provide informed consent; Target vessel has been previously treated with bypass; or Enrolled in concurrent clinical study. Angiographic Exclusion Criteria • Target vessel: Shows evidence of previous dissection or perforation, or Has adjacent acute thrombus; or Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robotic-assisted PVI<br>Robotic-assisted peripheral vascular intervention | Device: Robotic-assisted peripheral vascular intervention<br>* Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE). | 72 hours or hospital discharge, whichever comes first. | 
| Adverse Events | No device-related serious adverse events. | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator Radiation Exposure Dose | Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters | Procedure | 
| Patient Radiation Exposure Dose | Patient Radiation Dose-area-product (DAP) | Procedure |