Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

Not Applicable

• Conditions: Angina Pectoris
• Interventions: Procedure: NT SVG grafts

• Registration Number: NCT02158455
• Lead Sponsor: Region Örebro County

Brief Summary

The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2014-04-30
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Three vessel coronary artery disease

Exclusion Criteria

• 65 years or older
• Elevated creatinine
• Raynauds disease
• Vein stripping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RA grafts	NT SVG grafts	RA grafts randomized for revascularization of left or right coronary territory
NT SVG grafts	NT SVG grafts	NT SVG randomized for revascularization of left or right coronary territory

Primary Outcome Measures

Name	Time	Method
Graft patency	5 months	The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".

Trial Locations

Locations (1)

University hospital; 🇸🇪 Orebro, Sweden