Status:
COMPLETED
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery
Lead Sponsor:
Cardica, Inc
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
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 betwe...
Eligibility Criteria
Inclusion
- PRE-OPERATIVELY
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00355563
Start Date
June 1 2006
End Date
April 1 2008
Last Update
January 9 2009
Active Locations (1)
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1
St. Michael's Medical Center
Newark, New Jersey, United States, 07102