NCT02339857

Brief Summary

The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Status
completed

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

November 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

January 12, 2015

Last Update Submit

January 15, 2015

Conditions

Ischemic Heart DiseaseAtherosclerosis

Keywords

coronary artery bypass graftingsaphenous veingrafts

Outcome Measures

Primary Outcomes (1)

  • Total patency of the no-touch vein grafts.

    Mean time 8 years.

Study Arms (1)

No-touch vein grafts to LAD

Procedure: No-touch harvesting technique

Interventions

No-touch harvesting techniquePROCEDURE

The saphenous vein is harvested with a pedicle of surrounding tissue.

No-touch vein grafts to LAD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.

You may qualify if:

  • Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
  • Saphenous vein graft harvesting using the no-touch technique.
  • The saphenous vein anastomised to the left anterior descending artery.
  • Informed consent

You may not qualify if:

  • Allergy to contrast media.
  • Impaired renal function.
  • Inability to conduct the study according to protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial IschemiaAtherosclerosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Ninos Samano, MD

    Faculty of Medicine and Health, Örebro University, Örebro, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiothoracic surgeon

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 16, 2015

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Last Updated

January 16, 2015

Record last verified: 2015-01