Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)

NCT ID: NCT01310725

Last Updated: 2011-03-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-11-30

Brief Summary

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The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.

The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

Detailed Description

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Patients undergoing coronary artery bypass grafting are included in the study.

Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.

The evaluation is made with angiography up to 5 years after surgery.

Conditions

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Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Coronary artery bypass grafting

Bypass of stenoses in coronary arteries using different types os vessels as conduit.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Isolated coronary artery disease embracing all three main branches of the coronary artery tree.

Exclusion Criteria

* Kidney insufficiency (Creatinine \> 120 µmol/L)
* War-farin anticoagulation therapy
* Ejection fraction \< 40%
* Repeat operation
* Other concurrent sur-gery
* Signs of reduced circulation in non-dominant hand
* Other severe illness, or if the patient declines to participate.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Regional Clinical Research

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Orebro

Principal Investigators

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Lars Norgren, MD, PhD, Prof.

Role: STUDY_CHAIR

OREBRO UNIVERSITY

Locations

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Dept of Cardiothoracic Surgery, Orebro University Hospital

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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mdr001

Identifier Type: -

Identifier Source: org_study_id

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