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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Cardica, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cardica, Inc
ClinicalTrials.gov Identifier:
NCT00292500
First received: February 14, 2006
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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
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
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: Ric Ruedy, Vice President, RA/CA/QA, Cardica, Inc.
ClinicalTrials.gov Identifier: NCT00292500     History of Changes
Other Study ID Numbers: IP2004-06
Study First Received: February 14, 2006
Last Updated: January 9, 2009
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 May 16, 2013