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| Sponsored by: |
Cardica, Inc |
| Information provided by: | Cardica, Inc |
| ClinicalTrials.gov Identifier: | NCT00292500 |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 170 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | August 2007 |
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 |
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| 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 |
| 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 | |||||
| Cardica, Inc |
| 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 |
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