The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary
angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary
saphenous vein bypass graft lesions.
Device: Xience V coronary stent
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Locations near you
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Full eligibility criteria for NCT00911976
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Age > 18 years
Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent
Use of an embolic protection device during the SVG intervention
Able and willing to return for angiographic follow-up after 12 months
Agree to participate and provide informed consent
Use of stents other than the Xience V stent
Planned non-cardiac surgery within the following 12 months
Presentation with an ST-segment elevation acute myocardial infarction
Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
Hemorrhagic diatheses, or refusal to receive blood transfusions
Current treatment with warfarin
Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
Coexisting conditions that limit life expectancy to less than 12 months
Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
Patients allergic to contrast material that can not be adequately premedicated
History of an allergic reaction or significant sensitivity to everolimus
Documented left ventricular ejection fraction (LVEF) < 25% at most recent evaluation
All locations for NCT00911976
United States (1)
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
View full eligibility
Tris trial is registered with FDA with number: NCT00911976. The sponsor of the trial is North Texas Veterans Healthcare System and it is looking for 40 volunteers for the current phase.
Official trial title: Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)
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