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

NCT ID: NCT00292500

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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CABG, anastomotic device; myocardial revascularization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C-Port

Automated distal anastomotic device

Group Type NO_INTERVENTION

Automated distal anastomotic device

Intervention Type DEVICE

CABG

Interventions

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Automated distal anastomotic device

CABG

Intervention Type DEVICE

Other Intervention Names

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C-Port xA Distal Anastomosis System

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardica, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Gummert, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Leipzig Gmbh

Locations

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Klinik für Herzchirurgie

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IP2004-06

Identifier Type: -

Identifier Source: org_study_id