Assessing Vein Graft Properties Between Conventional & No-Touch Harvesting Technique - (PATENT SVG)

December 11, 2012 updated by: Stephen E. Fremes, Sunnybrook Health Sciences Centre

Comparative Evaluation of Vasomotor Function in Saphenous Veins Harvested Using Pedicled vs Conventional Technique

The purpose of this study is to compare saphenous veins harvested using the atraumatic pedicled ("no-touch") technique to saphenous veins harvested using the conventional open technique in patients undergoing isolated coronary artery bypass surgery. Investigators will compare the biological structure of the saphenous veins harvested using these two techniques. There is some evidence that saphenous veins harvested using the "no-touch" technique may allow for better patency up to 8 years following bypass surgery. We may be able to detect early differences in vascular structure, observed at the time of conduit harvest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atherosclerosis is a complex, multifactorial inflammatory disease, which is initiated largely in areas of endothelial injury, secondary to biomechanical disturbances, or systemic factors such as lipoprotein disturbances, hypertension, diabetes, and smoking (the response to injury hypothesis). Accumulating data indicate that structural and/or functional alterations in endothelial integrity play a primordial role in the development of atherosclerosis via promoting aberrant interactions between modified lipoproteins, monocyte-derived macrophages, T cells and normal cellular elements of the arterial wall inciting early plaque formation. As such, strategies, either pharmacological or mechanical in nature which reduce and/or restore endothelial homeostasis remain an important cornerstone to limit atherosclerosis.

Investigators hypothesize that saphenous veins harvested using the atraumatic pedicled ("no-touch") technique from patients undergoing isolated coronary artery bypass surgery will exhibit superior indices of vasomotor structure compared to veins harvested using the conventional open technique. We anticipate that leg healing will not be significantly altered using the "no-touch" technique.

Eligible patients will have two SVG segments harvested, one from each lower leg. One leg will have the SVG harvested in the conventional fashion and the contralateral leg will have the SVG harvested using the "no touch" technique. This will be determined by block randomization revealed at the time of skin incision. For patients with very small lower leg saphenous veins, the surgical protocol would be to then use the thigh segment instead. Patients will have Duplex scans to evaluate saphenous veins pre-operatively.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • SunnyBrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age> 18 years and able to provide informed consent
  2. Requiring isolated, primary coronary artery bypass graft surgery
  3. Elective or urgent cases
  4. With or without the use or cardiopulmonary bypass
  5. Left ventricular ejection fraction > 20%
  6. Patient require at least 2 SVG's

Exclusion Criteria:

  1. Unable to give consent
  2. Unable to use bilateral lower greater saphenous veins ( severe peripheral vascular disease,varicose veins, previous vein stripping, previous amputation, inadequate ultrasound appearance )
  3. Pregnant women, women of child bearing age
  4. Preoperative persistent atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pedicled "no-touch" SVG harvesting
Saphenous vein harvested with a pedicle of surrounding fat and distension with heparinized blood at arterial pressure. No manual distention.
Procedure: Coronary Artery Bypass Graft Surgery
Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery
Other Names:
  • Pedicled "no-touch" saphenous vein graft harvesting
  • Conventional open saphenous vein graft harvesting
ACTIVE_COMPARATOR: Conventional open SVG harvesting
Saphenous vein is harvested with an open technique, stripped of adventitia, and manually distended with crystalloid solution.
Procedure: Coronary Artery Bypass Graft Surgery
Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery
Other Names:
  • Pedicled "no-touch" saphenous vein graft harvesting
  • Conventional open saphenous vein graft harvesting
Procedure: Conventional open SVG harvesting
SVG harvested using conventional open technique and manually distended with crystalloid solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological Properties
Time Frame: Characteristics of the tissue will be reflective of the status of the tissue on the day of surgery (day 0).

Segments of saphenous veins, approximately 5cm in length, harvested by either the conventional or no-touch technique will be employed.

Segments will be immediately frozen in liquid nitrogen for Western blot analysis. Another 5mm segment will be used for immediate measurement of superoxide (O2-) production. Two rings, approximately 5mm in length will be frozen in Tissue Teck and another one placed in formalin (4%) and then embedded in paraffin.
Characteristics of the tissue will be reflective of the status of the tissue on the day of surgery (day 0).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg wound Healing and Leg Functional Outcome
Time Frame: 12 months postoperatively
Leg wound healing and functional outcome will be assessed in both lower legs using a quality of life measurement tool.
12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 078-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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