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

August 19, 2013 updated by: Cardica, Inc
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, D-04289
        • Klinik für Herzchirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: C-Port
Automated distal anastomotic device
Device: Automated distal anastomotic device
CABG
Other Names:
  • C-Port xA Distal Anastomosis System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary patency of index graft at the sixth post-operative month
Time Frame: 6 months post-op
6 months post-op

Secondary Outcome Measures

Outcome Measure
Time Frame
Establish preliminary safety profile
Time Frame: 6 months post-op
6 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardica, Inc

Investigators

  • Principal Investigator: Jan Gummert, MD, Herzzentrum Leipzig GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (ESTIMATE)

February 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP2004-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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