Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
DEVICEPAS-Port Automated Proximal Anastomosis System
Sponsors
Cardica, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: Graft Patency at 9 months post-operatively | — |
| Safety: Peri-and Post-operative MACE and SAE | — |
Countries
United States
Outcome results
None listed