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Sponsored by: |
Cardica, Inc |
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Information provided by: | Cardica, Inc |
ClinicalTrials.gov Identifier: | NCT00355563 |
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 |
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Coronary Artery Disease |
Device: PAS-Port Automated Proximal Anastomosis System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery |
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) |
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PRE-OPERATIVELY
Inclusion Criteria:
Exclusion Criteria:
INTRA-OPERATIVELY
Inclusion Criteria:
Exclusion Criteria:
-Any of the Intra-operative Inclusion Criteria not met
Responsible Party: | Cardica, Inc. ( Ric Ruedy, Vice President, RA/CA/QA ) |
Study ID Numbers: | IP2005-07 |
Study First Received: | July 21, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00355563 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |