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

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310725
• Other study ID #: mdr001
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: March 7, 2011
• Start date: January 2004
• Est. completion date: November 2010

Study information

• Verified date: September 2010
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Procedure:
• Coronary artery bypass grafting
Bypass of stenoses in coronary arteries using different types os vessels as conduit.

Locations

Country	Name	City	State
Sweden	Dept of Cardiothoracic Surgery, Orebro University Hospital	Orebro

Sponsors (3)

Lead Sponsor	Collaborator
Region Örebro County	Regional Clinical Research, Swedish Heart Lung Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional grafts defined as opened or closed.		Up to 5 years after surgery.
Secondary	Degree of stenosis in implanted grafts.		Up to 5 years after surgery.