Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

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

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.

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.

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.