Cardica C - Port xA * Anastomotic System

Coronary Artery Disease (CAD) is the leading cause of death in our society.
Either Percutaneous Transluminal Coronary Angioplasty (PTCA), with or without
stenting, or Coronary Artery ByPass Grafting (CABG) procedures are typically
employed to achieve revascularization of the heart. The Cardica * C - Port xA
is intended for use in CABG procedures for creating a rapid sutureless end to
side directional distal anastomosis between a grafted vessel (vein or artery)
and the coronary artery. The Cardica * C - Port xA has three possible
advantages compared to the standard suturing technique: The Cardica * C - Port
xA may provide a method for standardizing the anastomosis procedure. Usage of
the Cardica * C - Port xA may shorten the actual *suturing* period of 10-25
minutes and the period of myocardial ischemia associated with local occlusion
of a coronary vessel in OPCAB procedures. For OPCAB cases, shortening the time
needed for graft connection will reduce the period of hemodynamic instability
frequently associated with heart displacement needed for back wall vessels
exposure. Finally, the anastomosis created with a C-Port xA is compliant as
opposed to an anastomosis created using the standard running suturing
technique, where the anastomosis is non-compliant and is restricted in its
ability to expand with increasing blood flow requirements.

The purpose of this study is to demonstrate equivalency of the Cardica * C -
Port Xa anastomosis compared to hand sutured anastomoses in patients
undergoing CABG with respect to 12 months patency at distal anastomosis site.

Patients planned to undergo a CABG procedure and agree to participate in the
study (signed informed consent) will be randomized to either the
investigational device or to a conventional hand suture technique group. The
operation will be a routine CABG procedure according to the hospital practice;
the only difference is the creation of the anastomosis using the device in
patients randomized to the investigational device group. Post operation, the
patients will be treated according to the Hospital normal practice. The
patients will be asked to return to a follow up visits at 6 months post
hospital discharge, at which time an ECG will be performed, blood pressure,
anginal status and anticoagulant medications will be collected. At 12 - month
follow up visit a Multislice Computed Tomography (MS - CT scan) will be
performed and patency information recorded on all study vessels. Clinical
evaluation, ECG, blood pressure, anginal status and cardiovascular and
anti-coagulant medication will be recorded.

Facilitating distal anastomoses with mechanical connector device.

Involved with the procedures are similar to risks in standard CABG procedures,
in particular: death, during and post procedure myocardial infarction,
cerebrovascular event, post operative bleeding and tamponade, coronary
occlusion (thrombosis) or spasm, arterial dissection, sternal or other wound
infection, sepsis, need for CABG reoperation, arrhythmia, drug induced side
effects, aortic aneurysm, pneumonia, stress ulcer or GI bleeding and post CABG
anginal syndrome. Total procedure time for deployment is expected to be 30
seconds. The loading of the device is normally done prior to cardiopulmonary
bypass. The loading time may vary with surgical training, and realistically be
within 1 and 10 minutes. However, the patient will not be exposed to prolonged
bypass time because of this.

There are general risks associated with a CT scan. Patients will be exposed to
radiation during the CT - scan which could amount as maximum up to 5,5 +/- 3.1
mSv. For comparison, the average annual radiation exposure that a person can
expect to experience from natural environmental causes in the Netherlands is
approximately 2,1 mSv per year. And yearly dose limitation for people working
in radiation rich environments, such as radiologists, is determined by law at
20 mSv