Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

June 4, 2014 updated by: Mats Dreifaldt, Region Örebro County

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Orebro, Sweden, 70185
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Three vessel coronary artery disease

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NT SVG grafts
NT SVG randomized for revascularization of left or right coronary territory
Procedure: NT SVG grafts
Active Comparator: RA grafts
RA grafts randomized for revascularization of left or right coronary territory
Procedure: NT SVG grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft patency
Time Frame: 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".
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTSVGRA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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