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

NCT01488084 | Completed Phase 1

• 1 other identifier: 078-2009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Leg wound Healing and Leg Functional Outcome

  12 months postoperatively

Study Arms (2)

Pedicled "no-touch" SVG harvesting

EXPERIMENTAL

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

Conventional open SVG harvesting

ACTIVE COMPARATOR

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

Procedure: Coronary Artery Bypass Graft Surgery; Procedure: Conventional open SVG harvesting

Interventions

Coronary Artery Bypass Graft Surgery PROCEDURE

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

Also known as: Pedicled "no-touch" saphenous vein graft harvesting, Conventional open saphenous vein graft harvesting

Conventional open SVG harvesting; Pedicled "no-touch" SVG harvesting

Conventional open SVG harvesting PROCEDURE

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

Conventional open SVG harvesting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 24327455 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Stephen Fremes, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Cardiac and Vascular Surgery

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: December 8, 2011
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

CA (1)