CompletedPhase 4

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

United States40 participantsStarted 2009-05

Plain-language 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 bypass graft lesions.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography

Timeframe: 12 months

Trial details

NCT IDNCT00911976

SponsorNorth Texas Veterans Healthcare System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2011-07

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