NCT01310725

Brief Summary

The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting. The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2004

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
Last Updated

March 8, 2011

Status Verified

September 1, 2010

Enrollment Period

6.8 years

First QC Date

March 7, 2011

Last Update Submit

March 7, 2011

Conditions

Angina Pectoris

Keywords

CABGLIMAsaphenous veinradial artery

Outcome Measures

Primary Outcomes (1)

  • Functional grafts defined as opened or closed.

    Up to 5 years after surgery.

Secondary Outcomes (1)

  • Degree of stenosis in implanted grafts.

    Up to 5 years after surgery.

Interventions

Coronary artery bypass graftingPROCEDURE

Bypass of stenoses in coronary arteries using different types os vessels as conduit.

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated coronary artery disease embracing all three main branches of the coronary artery tree.

You may not qualify if:

  • Kidney insufficiency (Creatinine \> 120 µmol/L)
  • War-farin anticoagulation therapy
  • Ejection fraction \< 40%
  • Repeat operation
  • Other concurrent sur-gery
  • Signs of reduced circulation in non-dominant hand
  • Other severe illness, or if the patient declines to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Cardiothoracic Surgery, Orebro University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Lars Norgren, MD, PhD, Prof.

    OREBRO UNIVERSITY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

January 1, 2004

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 8, 2011

Record last verified: 2010-09

Locations

SE(1)