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Clinical Trials/NCT01860274
NCT01860274
Completed
Not Applicable

External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome

Cardiochirurgia E.H.2 sites in 1 country102 target enrollmentSeptember 6, 2015
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Cardiochirurgia E.H.
Enrollment
102
Locations
2
Primary Endpoint
Patency
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.

To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.

Registry
clinicaltrials.gov
Start Date
September 6, 2015
End Date
June 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cardiochirurgia E.H.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
  • •Coronary artery with critical stenosis (over 70%)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patency

Time Frame: 6 to 12 months

Patency of graft at CT Scan

Secondary Outcomes

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE)(60 months)
  • Vein graft lumen uniformity(6 to 12 months)

Study Sites (2)

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