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

Primary Purpose

Coronary Artery Disease

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Automated distal anastomotic device

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, anastomotic device; myocardial revascularization

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik für Herzchirurgie

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

C-Port

Arm Description

Automated distal anastomotic device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Establish preliminary safety profile

Full Information

NCT ID

NCT00292500

First Posted

February 14, 2006

Last Updated

August 19, 2013

Sponsor

Cardica, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00292500

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Terminated

Why Stopped

Cardica has terminated the development of the product for Business Reason.

Study Start Date

January 2006 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardica, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

CABG, anastomotic device; myocardial revascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C-Port

Arm Type

No Intervention

Arm Description

Automated distal anastomotic device

Intervention Type

Device

Intervention Name(s)

Automated distal anastomotic device

Other Intervention Name(s)

C-Port xA Distal Anastomosis System

Intervention Description

CABG

Primary Outcome Measure Information:

Title

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

Time Frame

6 months post-op

Secondary Outcome Measure Information:

Title

Establish preliminary safety profile

Time Frame

6 months post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Gummert, MD

Organizational Affiliation

Herzzentrum Leipzig Gmbh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Herzchirurgie

City

Leipzig

ZIP/Postal Code

D-04289

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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