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Completed

NCT Number: NCT01686100

CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency.

The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years.

This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital

Örebro, 70185, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
  • Included in the previous follow up studies
  • Signed and dated consent.

Exclusion criteria

  • Allergy to contrast
  • Renal failure
  • Uncontrolled diabetes
  • Unable to implement the study according to protocol -

Treatment and study plan

No touch technique

Procedure

The vein graft is harvested with its surronding tissues.

Conventional technique

Procedure

The vein graft is stripped from its surrounding tissues.

Primary outcomes

  1. Patency of the grafts

    Time frame: Mean time of 15 years.

Secondary outcomes

  1. Stenosis in the grafts.

    Time frame: Mean time of 15 years.

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Registry information

Official study title

CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2012
Registry last updated
Sep 19, 2012

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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