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

January 8, 2009 updated by: Cardica, Inc

Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • St. Michael's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effectiveness: Graft Patency at 9 months post-operatively
Safety: Peri-and Post-operative MACE and SAE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardica, Inc

Investigators

  • Principal Investigator: John Puskas, M.D., Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 21, 2006

First Submitted That Met QC Criteria

July 21, 2006

First Posted (Estimate)

July 24, 2006

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP2005-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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