Objective The study objective was to evaluate the safety and technical efficacy of the CorPath 200 System in delivery and manipulation of commercially available coronary guidewires and rapid exchange balloon/stent catheter for use in percutaneous coronary interventions (PCI).
I. Primary Endpoints A. Efficacy Device Clinical Success: Achievement of a \< 30% final diameter stenosis after utilizing the CorPathTM 200 System to deliver a PTCA balloon and then stent to the target lesion, and successfully retract the devices without the occurrence of any In-Hospital MACE (Major Adverse Cardiac Event) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
B. Safety In-Hospital MACE: Defined as the composite of death (all cause mortality), recurrent MI, and target vessel revascularization (emergent coronary artery bypass surgery \[CABG\] or PCI) evaluated at 48 hours post procedure or hospital discharge, whichever occurs first.
II. Secondary Endpoints A. Efficacy CorPath Success: Ability to navigate the guide wire and balloon/stent system utilizing the CorPath™ device to the target site without the occurrence of any In-Hospital MACE, evaluated at 48 hours post index procedure or hospital discharge, whichever occurs first.
Subject Clinical Success: Achievement of a \<30% final diameter stenosis of target lesion after treatment with PTCA/coronary stent without the occurrence of any In-Hospital MACE, evaluated at 48 hours post-index procedure or hospital discharge, whichever occurs first.
B. Safety:
MACE at 30 Days: Defined as the composite of death, recurrent MI and/or target vessel revascularization (emergent coronary artery bypass surgery \[CABG\] or PCI) evaluated at 30 days post index procedure.
Adverse Events:
A summary of all adverse events observed in the trial summarized as either serious or non-serious and summarized by attribution.
C. Clinical Utility
Procedure Attributes:
* Reduction in radiation exposure to the primary operator based on radiation dosimetry measurements at the procedure table and on a primary operator.
* Total Procedure time based on the time of insertion of hemostasis sheath through the time of final guide catheter withdrawal.
CorPath Device Attributes:
Subjective assessment by the operator of the following device performance attributes:
* Movement of the guide wire (rotating and advancing) to the target.
* Maneuvering and position of the guide wire to the target.
* Movement of the stent/balloon (advancing) to the target.
* Ability to deliver the PTCA/stent system to the intended target lesion.
* Ease of use of the system by the interventional team.
Material \& Methods Corindus obtained approval (from the CORBIC Ethics Committee and INVIMA - Colombian Ministry of Health) in 2009 to conduct the clinical study "CorPath™ 200 System: Coronary Remote Catheterization Feasibility Study" at CORBIC Cardio-Neuro-Vascular Institute, Envigado, Colombia.
The study is a single arm, open label, prospective registry to treat a de novo lesion (2.5 mm - 4.0 mm in diameter, 25.0 mm in length with \>50% stenosis) utilizing the CorPath 200 System to deliver, manipulate and retrieve a guidewire and a balloon/stent catheter system.
