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Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
This study is ongoing, but not recruiting participants.
Study NCT00292500   Information provided by Cardica, Inc
First Received: February 14, 2006   Last Updated: January 9, 2009   History of Changes

February 14, 2006
January 9, 2009
January 2006
October 2008   (final data collection date for primary outcome measure)
Coronary patency of index graft at the sixth post-operative month [ Time Frame: 6 months post-op ] [ Designated as safety issue: Yes ]
Coronary patency of index graft at the sixth post-operatieve month
Complete list of historical versions of study NCT00292500 on ClinicalTrials.gov Archive Site
Establish preliminary safety profile [ Time Frame: 6 months post-op ] [ Designated as safety issue: Yes ]
Establish preliminary safety profile
 
Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

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.

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Coronary Artery Disease
Device: Automated distal anastomotic device
Other: CABG with subject device
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
170
March 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00292500
Ric Ruedy, Vice President, RA/CA/QA, Cardica, Inc.
IP2004-06
Cardica, Inc
 
Principal Investigator: Jan Gummert, MD Herzzentrum Leipzig Gmbh
Cardica, Inc
January 2009

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