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

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Stephen E. Fremes, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01488084
First received: November 7, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Coronary Artery Bypass Graft Surgery
Procedure: Conventional open SVG harvesting
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Vasomotor Function in Saphenous Veins Harvested Using Pedicled vs Conventional Technique

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Biological Properties [ Time Frame: Characteristics of the tissue will be reflective of the status of the tissue on the day of surgery (day 0). ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: Yes ]
    Leg wound healing and functional outcome will be assessed in both lower legs using a quality of life measurement tool.


Enrollment: 15
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Conventional open SVG harvesting

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488084

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Stephen Fremes, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Stephen E. Fremes, Head, Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01488084     History of Changes
Other Study ID Numbers: 078-2009
Study First Received: November 7, 2011
Last Updated: December 11, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Sunnybrook Health Sciences Centre:
Saphenous vein graft patency
Coronary artery bypass surgery
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014