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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Medizinische Univeristät Graz
Graz, Austria
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).
Time frame: 72 hours or hospital discharge, whichever comes first.
Adverse Events
No device-related serious adverse events.
Time frame: Procedure
Operator Radiation Exposure Dose
Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters
Time frame: Procedure
Patient Radiation Exposure Dose
Patient Radiation Dose-area-product (DAP)
Time frame: Procedure
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