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

Tracking Information

First Received Date ^ICMJE

February 14, 2006

Last Updated Date

January 9, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00292500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Establish preliminary safety profile

Descriptive Information

Brief Title ^ICMJE

Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

Official Title ^ICMJE

Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Device: Automated distal anastomotic device

Study Arms / Comparison Groups

Other: CABG with subject device

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

170

Estimated Completion Date

March 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00292500

Responsible Party

Ric Ruedy, Vice President, RA/CA/QA, Cardica, Inc.

Study ID Numbers ^ICMJE

IP2004-06

Study Sponsor ^ICMJE

Cardica, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jan Gummert, MD

Herzzentrum Leipzig Gmbh

Information Provided By

Cardica, Inc

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP