Seoul National Uinversity Hospital
Seoul, 110 744, South Korea
NCT Number: NCT01051986
The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.
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Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Seoul, 110 744, South Korea
The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
use saphenous vein as a composite graft connected to the left internal thoracic artery
Other names: SAVERITA SVG
right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
Other names: SAVERITA RITA
Time frame: one year
1 year graft patency of second limb conduits measured by 1 year coronary angiography
Time frame: 4 years
Overall survival rate at 4 years
Time frame: 4 years
Freedom rate from cardiac death at 4 years
Time frame: 4 years
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Time frame: 1.4days
The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
Seoul National University Hospital
Other
A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
Acronym: SAVERITA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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