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Clinical Trials/NCT01834846
NCT01834846
Unknown
Not Applicable

Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.

Norwegian University of Science and Technology1 site in 1 country100 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
Norwegian University of Science and Technology
Enrollment
100
Locations
1
Primary Endpoint
Graft function
Last Updated
5 years ago

Overview

Brief Summary

The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Isolated elective, primary CABG requiring cardiopulmonary bypass
  • Left ventricular ejection fraction \>35%
  • at least one saphenous vein graft required as part of revascularization strategy

Exclusion Criteria

  • Acute or chronic inflammatory diseases
  • Malignancies
  • Pregnancy
  • Previous cardiac surgery
  • Serum creatinine \>120 μmol/L
  • Coagulopathy
  • Insulin dependent diabetes mellitus
  • Smoking during last 6 months
  • Leg not suitable for No-touch vein harvesting as judged by the operator.
  • Need for nitrates on operation day

Outcomes

Primary Outcomes

Graft function

Time Frame: 5 years

Graft function as evaluated by coronary angiography in all 100 patients

Secondary Outcomes

  • Morphological appearance of vein graft(5 years)
  • Postoperative leg wound complications(6 weeks)
  • Postoperative complications related to cardiac surgery(5 years)

Study Sites (1)

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