Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
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|ClinicalTrials.gov Identifier: NCT01540422|
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : March 17, 2015
|Condition or disease|
|Coronary Artery Disease|
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:
- Intra-operatively by transit time graft flow measurements.
- Post-operative Day 30 through Cardiac CT Angiography.
- Post-operative Month 12 through Cardiac CT Angiography.
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
CABG w/saphenous vein grafts harvested using endoscopy
Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques
- Improved vein graft patency [ Time Frame: 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.
- Vein graft failure [ Time Frame: Baseline, 30 days, and 12 months ]
- Assess the incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements.
- Incidence of vein graft failure at postoperative day 30 as evaluated by Coronary CT angiography
- Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography
Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
- Harvested vessel (greater versus lesser saphenous vein)
- Vein graft destinations
- Vein graft quality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540422
|United States, Texas|
|Medical City Hospital|
|Dallas, Texas, United States, 75230|
|The Heart Hospital Baylor Plano|
|Plano, Texas, United States, 75093|