Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions

Completed · Phase 4

Conditions studied: Coronary Artery Bypass, Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00911976

Run by

North Texas Veterans Healthcare System

People needed

40

Starts

2009-05-01

Expected to finish

2011-07-01

Last updated by the study team

2012-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA North Texas Healthcare System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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