Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Swedish Heart Lung Foundation
Regional Clinical Research
Information provided by:
University Hospital Orebro Identifier:
First received: March 7, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 University Hospital Orebro:

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

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

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.


Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01310725

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

No publications provided

Responsible Party: University Hospital Orebro Identifier: NCT01310725     History of Changes
Other Study ID Numbers: mdr001
Study First Received: March 7, 2011
Last Updated: March 7, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:
saphenous vein
radial artery processed this record on March 03, 2015