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

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 anterio 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 an automated device versus hand-sewn grafts of the same vessels in the same patient population.

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

MedlinePlus related topics: Coronary Artery Disease Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Official Title:	Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

Further study details as provided by Cardica, Inc:

Primary Outcome Measures:

Coronary patency of index graft at the sixth post-operative month [ Time Frame: 6 months post-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Establish preliminary safety profile [ Time Frame: 6 months post-op ] [ Designated as safety issue: Yes ]

Enrollment:	170
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C-Port CABG with subject device	Device: Automated distal anastomotic device CABG

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 consent
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

Contacts and Locations

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

Locations

Germany
Klinik für Herzchirurgie
Leipzig, Germany, D-04289

Sponsors and Collaborators

Cardica, Inc

Investigators

Principal Investigator:

Jan Gummert, MD

Herzzentrum Leipzig Gmbh

More Information

No publications provided

Responsible Party:	Cardica, Inc. ( Ric Ruedy, Vice President, RA/CA/QA )
Study ID Numbers:	IP2004-06
Study First Received:	February 14, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00292500 History of Changes
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:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009