Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01540422
• Lead Sponsor: Baylor Research Institute

Brief Summary

The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.

Detailed Description

Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.

Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.

With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.

It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.

In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.

Vein graft patency will be evaluated:

1. Intra-operatively by transit time graft flow measurements.

2. Post-operative Day 30 through Cardiac CT Angiography.

3. Post-operative Month 12 through Cardiac CT Angiography.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 93

Inclusion Criteria

• Males and females at least 18 years of age and able to sign consent
• Undergoing CABG surgery
• Eligible for endoscopic saphenous vein harvesting
• A minimum of two non-sequential vein grafts will be performed
• Subject willing to comply with the requirements of the protocol

Exclusion Criteria

1. Previous CABG
2. Previous or concomitant valve surgery
3. Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
4. Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
5. Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
6. Abnormal platelet level defined as Plt Count >400,000
7. Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
8. Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
9. Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved vein graft patency	Baseline and 12 months	To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.

Secondary Outcome Measures

Name	Time	Method
Vein graft failure	Baseline, 30 days, and 12 months	1. Assess the incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements.; 2. Incidence of vein graft failure at postoperative day 30 as evaluated by Coronary CT angiography; 3. Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography; 4. Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by: 1. Harvested vessel (greater versus lesser saphenous vein); 2. Vein graft destinations; 3. Vein graft quality

Trial Locations

Locations (2)

Medical City Hospital; 🇺🇸 Dallas, Texas, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States