CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)

An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures.

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.

Eligibility Criteria:
General Inclusion Criteria:

* The subject is an acceptable candidate for PCI.
* The subject must have clinical evidence of ischemic heart disease or a positive functional study.
* Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within seven (7) days prior to index procedure.
* The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Angiographic Inclusion Criteria:

* Study lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
* The study lesion is intended to be treated with one stent. Maximum stent length allowed is 20 mm.
* The study reference vessel diameter is between 2.50 mm and 4.5 mm by visual estimate.
* Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

General Exclusion Criteria:

* Subject requires planned PCI or CABG within 30 days following the index procedure.
* Subject has evolving ST elevation myocardial infarction (STEMI) (i.e., beginning of MI symptoms within 72 hours prior to the planned index procedure).
* Subject has documented left ventricular ejection fraction \< 30%.
* Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
* Subject has a platelet count \< 100,000 cell/mm3 or \> 700,000 cell/ mm3, a WBC of \< 3000 cell/ mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leucopenia).
* Subject has a history of a stroke (CVA) or TIA within 30-days prior to planned index procedure.
* Subject has an active peptic ulcer or upper GI bleeding within the 6 months prior to planned index procedure.
* Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Subject is currently participating in another investigational drug l drug or device trial that has not completed the entire follow up period.

Angiographic Exclusion Criteria:

* Study lesion that cannot be fully covered by a single stent of maximal length
* Subject requires treatment of multiple lesions in the study vessel at the time of index procedure.
* The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement.
* The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (\> 90o) proximal to the target lesion.
* The study lesion has any of the following characteristics:

  1. Total occlusion
  2. Ostial location
  3. Involves a side branch \> 2.0 mm vessel diameter
  4. Is located at \>45° bend in the vessel
  5. Is moderately to severely calcified
  6. Moderate-to-severe calcification at the part of the vessel prior to target lesion
* Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery).