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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488084
• Other study ID #: 078-2009
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2011
• Last updated: December 11, 2012
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary Artery Bypass Graft Surgery
Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery
• Conventional open SVG harvesting
SVG harvested using conventional open technique and manually distended with crystalloid solution

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Characteristics of the tissue will be reflective of the status of the tissue on the day of surgery (day 0).	No
Secondary	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.	12 months postoperatively	Yes