This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Medizinische Univeristät Graz
Graz, Austria
Device Technical Success
Number of lesions for which there was technical success" as accurate and appropriate.
Time frame: Procedure
Adverse Events
No device-related serious adverse events during the procedure.
Time frame: Procedure
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.
Time frame: 24-hours
Fluoroscopy Time
As recorded by an X-ray system utilized during the procedure.
Time frame: Procedure
Contrast Volume
Total amount of contrast used during CorPath procedure.
Time frame: Procedure
Total Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).
Time frame: Procedure
Interventional Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Time frame: Procedure
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