Status:
COMPLETED
Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions
Lead Sponsor:
North Texas Veterans Healthcare System
Conditions:
Coronary Artery Bypass
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 bypa...
Detailed Description
Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00911976
Start Date
May 1 2009
End Date
July 1 2011
Last Update
October 26 2012
Active Locations (1)
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1
VA North Texas Healthcare System
Dallas, Texas, United States, 75216