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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: No touch technique; Procedure: Conventional technique

• Registration Number: NCT01686100
• Lead Sponsor: Örebro County Council

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-17
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

1. Allergy to contrast
2. Renal failure
3. Uncontrolled diabetes
4. Unable to implement the study according to protocol -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No touch vein grafts	No touch technique	The grafts were harvested with there surrounding tissues.
Conventional vein grafts.	Conventional technique	The grafts were stripped from surrounding tissue.

Primary Outcome Measures

Name	Time	Method
Patency of the grafts	Mean time of 15 years.

Secondary Outcome Measures

Name	Time	Method
Stenosis in the grafts.	Mean time of 15 years.

Trial Locations

Locations (1)

Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital; 🇸🇪 Örebro, Sweden