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

NCT00355563 | Completed Phase 3 DMC

• 1 other identifier: IP2005-07
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness: Graft Patency at 9 months post-operatively

• Safety: Peri-and Post-operative MACE and SAE

Interventions

PAS-Port Automated Proximal Anastomosis System DEVICE

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient is hemodynamically stable

Sponsors & Collaborators

• Cardica, Inc: lead

Study Sites (1)

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John Puskas, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 24, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

US (1)