Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
Completed
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01540422
- Run by
- Baylor Research Institute
- People needed
- 93
- Starts
- 2010-10-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-03-17
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous CABG
- Previous or concomitant valve surgery
- Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
- Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
- Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
- Abnormal platelet level defined as Plt Count >400,000
- Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
- Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
- Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein
Where it is running
- Medical City Hospital — Dallas, Texas, United States
- The Heart Hospital Baylor Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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