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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310725
First Posted: March 8, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swedish Heart Lung Foundation
Regional Clinical Research
Information provided by:
Region Örebro County
  Purpose

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.


Condition Intervention
Angina Pectoris Procedure: Coronary artery bypass grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Region Örebro County:

Primary Outcome Measures:
  • Functional grafts defined as opened or closed. [ Time Frame: Up to 5 years after surgery. ]

Secondary Outcome Measures:
  • Degree of stenosis in implanted grafts. [ Time Frame: Up to 5 years after surgery. ]

Enrollment: 108
Study Start Date: January 2004
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Coronary artery bypass grafting
    Bypass of stenoses in coronary arteries using different types os vessels as conduit.
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310725


Locations
Sweden
Dept of Cardiothoracic Surgery, Orebro University Hospital
Orebro, Sweden, 701 85
Sponsors and Collaborators
Region Örebro County
Swedish Heart Lung Foundation
Regional Clinical Research
Investigators
Study Chair: Lars Norgren, MD, PhD, Prof. Orebro University
  More Information

Responsible Party: University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01310725     History of Changes
Other Study ID Numbers: mdr001
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: October 12, 2017
Last Verified: September 2010

Keywords provided by Region Örebro County:
CABG
LIMA
saphenous vein
radial artery

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms