A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The LIBERTY® Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature. The LIBERTY® Robotic System is not intended for coronary or neurointerventional procedures.
Baptist Hospital of Miami
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Effectiveness Endpoint
Successful robotic navigation of the guidewire and microcatheter is defined as reaching at least 95% of the predetermined anatomical target locations using the LIBERTY® Robotic System, without switching from a robotic to manual procedure due to difficulty reaching the target site.
Time frame: During navigation portion of the procedure.
Safety Endpoint
Safety of the LIBERTY® Robotic System will be evaluated by the number and rate of Adverse Device Effects (ADEs) reported
Time frame: Through the three (3) day follow-up visit period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.