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

NCT ID: NCT00355563

Last Updated: 2009-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

PAS-Port Automated Proximal Anastomosis System

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardica, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Cardica, Inc.

Principal Investigators

John Puskas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

St. Michael's Medical Center

Newark, New Jersey, United States

Countries

United States

Other Identifiers

IP2005-07

Identifier Type: -

Identifier Source: org_study_id