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Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

NCT ID: NCT02158455

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NT SVG grafts

NT SVG randomized for revascularization of left or right coronary territory

Group Type EXPERIMENTAL

NT SVG grafts

Intervention Type PROCEDURE

RA grafts

RA grafts randomized for revascularization of left or right coronary territory

Group Type ACTIVE_COMPARATOR

NT SVG grafts

Intervention Type PROCEDURE

Interventions

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NT SVG grafts

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Three vessel coronary artery disease

Exclusion Criteria

* 65 years or older
* Elevated creatinine
* Raynauds disease
* Vein stripping
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Mats Dreifaldt

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NTSVGRA

Identifier Type: -

Identifier Source: org_study_id

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