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

This study has been terminated.
(Cardica has terminated the development of the product for Business Reason.)
Sponsor:
Information provided by (Responsible Party):
Cardica, Inc
ClinicalTrials.gov Identifier:
NCT00292500
First received: February 14, 2006
Last updated: August 19, 2013
Last verified: August 2013
  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
Coronary Artery Disease
Device: Automated distal anastomotic device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: December 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: C-Port
Automated distal anastomotic device
Device: Automated distal anastomotic device
CABG
Other Name: C-Port xA Distal Anastomosis System

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00292500     History of Changes
Other Study ID Numbers: IP2004-06
Study First Received: February 14, 2006
Last Updated: August 19, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Cardica, Inc:
CABG, anastomotic device; myocardial revascularization

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014