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

NCT ID: NCT01488084

Last Updated: 2012-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-11-30

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.

Conditions

Coronary Artery Disease

Keywords

Saphenous vein graft patency; Coronary artery bypass surgery; Coronary artery disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coronary Artery Bypass Graft Surgery

Intervention Type: PROCEDURE

Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery

Conventional open SVG harvesting

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

Group Type: ACTIVE_COMPARATOR

Coronary Artery Bypass Graft Surgery

Intervention Type: PROCEDURE

Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery

Conventional open SVG harvesting

Intervention Type: PROCEDURE

SVG harvested using conventional open technique and manually distended with crystalloid solution

Interventions

Coronary Artery Bypass Graft Surgery

Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery

Intervention Type: PROCEDURE

Conventional open SVG harvesting

SVG harvested using conventional open technique and manually distended with crystalloid solution

Intervention Type: PROCEDURE

Other Intervention Names

Pedicled "no-touch" saphenous vein graft harvesting; Conventional open saphenous vein graft harvesting

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Stephen E. Fremes

Head, Division of Cardiac and Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Fremes, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24327455 (View on PubMed)

Other Identifiers

078-2009

Identifier Type: -

Identifier Source: org_study_id