The SOS (Stenting Of Saphenous Vein Grafts) Trial (NCT00247208) | Clinical Trial Compass
CompletedPhase 3
The SOS (Stenting Of Saphenous Vein Grafts) Trial
United States, Greece80 participantsStarted 2005-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography