Overview

This trial is active, not recruiting.

Condition angina pectoris
Treatment nt svg grafts
Sponsor University Hospital Orebro
Start date February 2004
End date December 2014
Trial size 108 participants
Trial identifier NCT02158455, NTSVGRA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
NT SVG randomized for revascularization of left or right coronary territory
nt svg grafts
(Active Comparator)
RA grafts randomized for revascularization of left or right coronary territory
nt svg grafts

Primary Outcomes

Measure
Graft patency
time frame: 5 months

Eligibility Criteria

Male or female participants up to 65 years old.

Inclusion Criteria: - Three vessel coronary artery disease Exclusion Criteria: - 65 years or older - Elevated creatinine - Raynauds disease - Vein stripping

Additional Information

Official title No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University Hospital Orebro.