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

This study has been completed.
Sponsor:
Information provided by:
Cardica, Inc
ClinicalTrials.gov Identifier:
NCT00355563
First received: July 21, 2006
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: PAS-Port Automated Proximal Anastomosis System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Cardica, Inc:

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

Estimated Enrollment: 220
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355563

Locations
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Cardica, Inc
Investigators
Principal Investigator: John Puskas, M.D. Emory University
  More Information

No publications provided

Responsible Party: Ric Ruedy, Vice President, RA/CA/QA, Cardica, Inc.
ClinicalTrials.gov Identifier: NCT00355563     History of Changes
Other Study ID Numbers: IP2005-07
Study First Received: July 21, 2006
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014