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Clinical Trials/NCT00265499
NCT00265499CompletedNot Applicable

Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting

University of Ottawa2 sites in 1 country48 target enrollmentStarted: December 14, 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
2
Primary Endpoint
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses

Study Overview

Brief Summary

The purpose of this study is to determine whether skeletonization of the internal thoracic artery leads to improved flow, increased length, improved sternal perfusion, and decreased pain and dysesthesia in patients undergoing coronary artery bypass surgery

Detailed Description

Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Although the benefits of ITA use are well established, there are certain limitations to its routine use. Recent studies, primarily observational, have suggested that skeletonization of the ITA (i.e. harvesting of the ITA alone) may overcome some of these limitations by improving conduit flow, increasing length, and reducing the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, this is a prospective, randomized, within-patient study design in patients undergoing coronary artery bypass grafting.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing bilateral internal thoracic artery harvest for coronary artery bypass surgery

Exclusion Criteria

  • Inability to speak English or French
  • Inability to complete follow-up visits

Outcomes

Primary Outcomes

Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses

Secondary Outcomes

  • - Internal Thoracic Artery length
  • - Sternal Perfusion (SPECT imaging)
  • - Post-operative pain and dysesthesia

Investigators

Sponsor Class
Other

Study Sites (2)

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