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Completed

NCT Number: NCT01310725

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

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.

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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Cardiothoracic Surgery, Orebro University Hospital

Örebro, 701 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary artery bypass grafting

Procedure

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

Primary outcomes

  1. Functional grafts defined as opened or closed.

    Time frame: Up to 5 years after surgery.

Secondary outcomes

  1. Degree of stenosis in implanted grafts.

    Time frame: Up to 5 years after surgery.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Regional Clinical Research
  • Swedish Heart Lung Foundation

Registry information

Official study title

Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 8, 2011
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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