Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II - Full Text View

Purpose

This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterios descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using and automated device versus hand-sewn grafts of the same vessels in the same patient population.compare the patency of automated

Condition	Intervention	Phase
Coronary Artery Disease	Device: Automated distal anastomotic device	Phase I Phase II

MedlinePlus related topics:

Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Cardica, Inc:

Primary Outcome Measures:

Coronary patency of index graft at the sixth post-operatieve month

Secondary Outcome Measures:

Establish preliminary safety profile

Estimated Enrollment:	170
Study Start Date:	January 2006
Estimated Study Completion Date:	August 2007

Detailed Description:

Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.

Eligibility

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

Criteria

Inclusion Criteria: Age between 50 and 85 years (inclusive), diagnostically confirmed coronary disease, ejection fraction>30%, tolerate contrast media, acceptable LIMA (conduit) and LAD (target)for grafting,life expectancy > 1 year -

Exclusion Criteria: Refusal to give informed consentm unable to meet study travel and general health requirements, pregnancy, previous cardiac surgery, NYHA Class IV, Preoperative need for IABP, acute or chronic dialysis (creatinine > 200mmolor 2.3 mg/dL) within 30 days of surgery. acute or suspected systemic infection, need for ongoing immunosuppressive therapy, recent history (<2 weeks) of CVA, aspirin allergy

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292500

Contacts


Contact: Jan Gummert, MD	+49 341 865 1422	gumj@medizin.uni-leipzig.de

Contact: Klaus Matschke, MD	+49 351 450 1800	klaus.matschke.hkz.dd@t-online.de

Locations


Germany
	Klinik für Herzchirurgie	Recruiting
	Leipzig, Germany, D-04289
	Contact: Jan Gummert, MD +49 341 865 1422 gumj@medizin.uni-leipzig.de
	Contact: Klaus Matschke, MD +49 351 450 1800 klaus.matschke.hkz.dd@t-online.de
	Principal Investigator: Jan Gummert, MD

Sponsors and Collaborators

Cardica, Inc

Investigators


Principal Investigator:	Jan Gummert, MD	Herzzentrum Leipzig Gmbh

More Information

Study ID Numbers:	IP2004-06
First Received:	February 14, 2006
Last Updated:	February 14, 2006
ClinicalTrials.gov Identifier:	NCT00292500
Health Authority:	Germany: Ethics Commission

Keywords provided by Cardica, Inc:

CABG, anastomotic device; myocardial revascularization

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Cardica, Inc
Information provided by:	Cardica, Inc
ClinicalTrials.gov Identifier:	NCT00292500