Status:
COMPLETED
The SOS (Stenting Of Saphenous Vein Grafts) Trial
Lead Sponsor:
North Texas Veterans Healthcare System
Collaborating Sponsors:
Clark R. Gregg Fund, Harris Methodist Foundation
University of Arkansas
Conditions:
Coronary Artery Bypass
Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mon...
Detailed Description
Introduction: The prevalence of coronary artery bypass graft (CABG) surgery is high in the veteran population. Saphenous veins are used as conduits in the majority of CABG operations. Compared to arte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00247208
Start Date
May 1 2005
End Date
June 1 2011
Last Update
April 26 2012
Active Locations (5)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
VA Iowa City Healthcare system
Iowa City, Iowa, United States, 52246
3
VA North Texas Health Care System
Dallas, Texas, United States, 75216
4
Michael E. Debakey VA Medical Center
Houston, Texas, United States, 77030