The SOS (Stenting Of Saphenous Vein Grafts) Trial

Completed · Phase 3

Conditions studied: Coronary Artery Bypass, Arteriosclerosis

In brief

The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.

Key facts

Study ID

NCT00247208

Run by

North Texas Veterans Healthcare System

People needed

80

Starts

2005-05-01

Expected to finish

2011-06-01

Last updated by the study team

2012-04-26

Who can join

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

You may qualify if…

• at least one 50-99% de-novo or restenotic lesion in a saphenous vein graft that is between 2.5 and 4.0 mm in diameter, requiring percutaneous coronary intervention according to the opinion of the attending cardiologist
• willing to return for repeat coronary angiography after 12 months
• able to give informed consent

You may not qualify if…

• previous or planned use of intravascular brachytherapy in the target vessel
• a left ventricular ejection fraction of less than 25 percent
• hemorrhagic diatheses
• contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel
• a history of anaphylaxis in response to iodinated contrast medium
• use of paclitaxel within 12 months before study entry or current use of colchicine
• a serum creatinine level of more than 2.0 mg per deciliter (177 µmol per liter)
• a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of less than 100,000 per cubic millimeter
• a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy
• coexisting conditions that limit life expectancy to less than 24 months or that could affect a patient's compliance with the protocol

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• VA Iowa City Healthcare system — Iowa City, Iowa, United States
• VA North Texas Health Care System — Dallas, Texas, United States
• Michael E. Debakey VA Medical Center — Houston, Texas, United States
• Onassis Cardiac Surgery Center — Athens, Greece

Full record on ClinicalTrials.gov

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