Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Study Overview
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Brief Summary
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This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.

Detailed Description
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The CorPath 200 System is currently marketed for remotely delivering guide wires, balloons and stents to blockages in the coronary arteries. This study will evaluate the feasibility of CorPath 200 System to deliver guide wires and balloons to blockages in non-coronary arteries. Guide wires and balloons are delivered to blockages in the lower limbs manually by doctors.If this study shows that guide wires and balloons can be safely delivered to blockages in the lower limbs, then it will be an alternative for physicians.

Official Title
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Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: CorPath 200 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion 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 iliac and/or superficial femoral arteries; The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent. Angiographic Inclusion Presence of superficial femoral artery and/or iliac stenosis (>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure. Exclusion Criteria: General Exclusion Failure/inability/unwillingness to provide informed consent; Target vessel has been previously treated with bypass; Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion; Has contraindication to anticoagulation; Has bleeding or a hypercoagulability disorder; Thrombocytopenia; Elevated international normalized ratio (>1.5); Elevated serum creatinine (≥2.5 mg/dL); Active infection; Contraindication to contrast; or Enrolled in concurrent clinical study. Angiographic Exclusion Target vessel: shows evidence of previous dissection or perforation, or has adjacent acute thrombus; Lesion is highly calcified; Lesion requires use of any atherectomy device during the procedure; 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 |
| --- | --- |
| Experimental: CorPath 200 System<br>CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. | Device: CorPath 200 System<br>* Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Technical Success | Number of lesions for which there was technical success as accurate and appropriate. | Procedure | 
| Adverse Events | No device-related serious adverse events during the procedure. | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Procedural Success | Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first. | 24-hours | 
| Fluoroscopy Time | As recorded by an X-ray system utilized during the procedure. | Procedure | 
| Contrast Volume | Total amount of contrast used during CorPath procedure. | Procedure | 
| Total Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed). | Procedure | 
| Interventional Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Critical Limb Ischemia, Claudication, Percutaneous Vascular Intervention, Peripheral Vascular Intervention