NCT02158455

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

10.8 years

First QC Date

April 30, 2014

Last Update Submit

June 4, 2014

Conditions

Angina Pectoris

Keywords

CABGSaphenous veinRadial artery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

NT SVG grafts

EXPERIMENTAL

NT SVG randomized for revascularization of left or right coronary territory

Procedure: NT SVG grafts

RA grafts

ACTIVE COMPARATOR

RA grafts randomized for revascularization of left or right coronary territory

Procedure: NT SVG grafts

Interventions

NT SVG graftsPROCEDURE
NT SVG graftsRA grafts

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Three vessel coronary artery disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 30, 2014

First Posted

June 6, 2014

Study Start

February 1, 2004

Primary Completion

December 1, 2014

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

SE(1)