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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Coronary Artery Bypass Graft Surgery
Conventional open SVG harvesting
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Saphenous vein graft patency, Coronary artery bypass surgery, Coronary artery disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pedicled "no-touch" SVG harvesting

Conventional open SVG harvesting

Arm Description

Saphenous vein harvested with a pedicle of surrounding fat and distension with heparinized blood at arterial pressure. No manual distention.

Saphenous vein is harvested with an open technique, stripped of adventitia, and manually distended with crystalloid solution.

Outcomes

Primary Outcome Measures

Biological Properties
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.

Secondary Outcome Measures

Leg wound Healing and Leg Functional Outcome
Leg wound healing and functional outcome will be assessed in both lower legs using a quality of life measurement tool.

Full Information

First Posted
November 7, 2011
Last Updated
December 11, 2012
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01488084
Brief Title
Assessing Vein Graft Properties Between Conventional & No-Touch Harvesting Technique - (PATENT SVG)
Official Title
Comparative Evaluation of Vasomotor Function in Saphenous Veins Harvested Using Pedicled vs Conventional Technique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Saphenous vein graft patency, Coronary artery bypass surgery, Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedicled "no-touch" SVG harvesting
Arm Type
Experimental
Arm Description
Saphenous vein harvested with a pedicle of surrounding fat and distension with heparinized blood at arterial pressure. No manual distention.
Arm Title
Conventional open SVG harvesting
Arm Type
Active Comparator
Arm Description
Saphenous vein is harvested with an open technique, stripped of adventitia, and manually distended with crystalloid solution.
Intervention Type
Procedure
Intervention Name(s)
Coronary Artery Bypass Graft Surgery
Other Intervention Name(s)
Pedicled "no-touch" saphenous vein graft harvesting, Conventional open saphenous vein graft harvesting
Intervention Description
Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery
Intervention Type
Procedure
Intervention Name(s)
Conventional open SVG harvesting
Intervention Description
SVG harvested using conventional open technique and manually distended with crystalloid solution
Primary Outcome Measure Information:
Title
Biological Properties
Description
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.
Time Frame
Characteristics of the tissue will be reflective of the status of the tissue on the day of surgery (day 0).
Secondary Outcome Measure Information:
Title
Leg wound Healing and Leg Functional Outcome
Description
Leg wound healing and functional outcome will be assessed in both lower legs using a quality of life measurement tool.
Time Frame
12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age> 18 years and able to provide informed consent Requiring isolated, primary coronary artery bypass graft surgery Elective or urgent cases With or without the use or cardiopulmonary bypass Left ventricular ejection fraction > 20% Patient require at least 2 SVG's Exclusion Criteria: Unable to give consent Unable to use bilateral lower greater saphenous veins ( severe peripheral vascular disease,varicose veins, previous vein stripping, previous amputation, inadequate ultrasound appearance ) Pregnant women, women of child bearing age Preoperative persistent atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Fremes, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24327455
Citation
Verma S, Lovren F, Pan Y, Yanagawa B, Deb S, Karkhanis R, Quan A, Teoh H, Feder-Elituv R, Moussa F, Souza DS, Fremes SE. Pedicled no-touch saphenous vein graft harvest limits vascular smooth muscle cell activation: the PATENT saphenous vein graft study. Eur J Cardiothorac Surg. 2014 Apr;45(4):717-25. doi: 10.1093/ejcts/ezt560. Epub 2013 Dec 9.
Results Reference
derived

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

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