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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography