Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery (EPIC)

Cardica

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Treatments

Device: PAS-Port Automated Proximal Anastomosis System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00355563

IP2005-07

Details and patient eligibility

About

The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary artery disease. Patients in the study will have a coronary angiogram approximately 9 months following surgery to determine the patency of vein grafts created using either the automated PAS-Port or hand sewn methods. Safety will be evaluated by documenting the occurence of adverse clinical events and evealuating possible association with either method.

Enrollment

220 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

PRE-OPERATIVELY

Inclusion Criteria:

Able to give informed consent, able to understand the intent and clinical meaning of the study as well as its implications. Patient is legally competent.
Assessment that the patient is willing and able to have follow-up visits and examinations
Age greater than or equal to 50 years and less than 85 years
Ejection fraction of >30%
Can tolerate radiographic contrast media
Requires non-emergent coronary artery bypass with at least two vein bypass grafts intended
Coronary artery targets intended for bypass index grafts must have >70% native stenosis
Life expectancy >1 year

Exclusion Criteria:

Patient is participating in other clinical trials that would conflict with this protocol
Unable to meet study requirements (travel, general health)
Pregnancy
Previous cardiac surgery
Requiring preoperative use of an intraaortic balloon pump
Congestive heart failure / NYHA Class IV
History of thromboembolic disease requiring ongoing anticoagulation therapy or the presence of a bleeding disorder
Acute or chronic dialysis
Creatinine of greater than 200 µmol/L (2.3 mg/dL) in the last 30 days
Documented acute or suspected systemic infection
Need for ongoing immunosuppressive therapy
Recent (less than 2 weeks) history of cerebrovascular accident
Aspirin allergy or other contraindications to aspirin use

INTRA-OPERATIVELY

Inclusion Criteria:

Patient is hemodynamically stable
Open chest reassessment of the revascularization strategy confirms that two vein bypass grafts are still intended
Target vessel wall properties that are suitable for performing both a hand-sewn and a PAS-Port anastomosis
Target vessel is greater than 1.8 mm in diameter at sites where anastomoses are planned
Target vessel at sites where anastomoses will be placed are free from severe calcifications or severe atheromas
The length of the vein graft(s) is adequate for both of the planned index graft revascularization strategies
Vein outside diameter and double wall thickness are between 4 and 6 mm(inclusive) and less than or equal to 1.4 mm, respectively, at the graft site intended for the PAS-Port proximal anastomosis
The vein(s) is of suitable quality to be used as a bypass graft conduit

Exclusion Criteria:

-Any of the Intra-operative Inclusion Criteria not met