Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

Angina Pectoris Clinical Trial

Official title:

No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02158455
• Other study ID #: NTSVGRA
• Status: Active, not recruiting
• Phase: N/A
• First received: April 30, 2014
• Last updated: June 4, 2014
• Start date: February 2004

Study information

• Verified date: June 2014
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

• Three vessel coronary artery disease

Exclusion Criteria:

• 65 years or older

• Elevated creatinine

• Raynauds disease

• Vein stripping

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Procedure:
• NT SVG grafts

Locations

Country	Name	City	State
Sweden	University hospital	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency	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".	5 months	No