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Sponsors and Collaborators: |
North Texas Veterans' Healthcare System Clark R. Gregg Fund, Harris Methodist Foundation University of Arkansas VA Iowa City Healthcare system, Iowa City, Iowa, United States Michael Debakey Veterans Affairs Medical Center Southern Arizona VA Health Care System Onassis Cardiac Surgery Centre |
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Information provided by: | North Texas Veterans' Healthcare System |
ClinicalTrials.gov Identifier: | NCT00247208 |
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.
Condition | Intervention | Phase |
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Coronary Artery Bypass Arteriosclerosis |
Device: Taxus polymer-based paclitaxel-eluting stent Device: Express 2 bare metal stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The SOS (Stenting Of Saphenous Vein Grafts) Randomized-Controlled Trial of a Paclitaxel-Eluting Stent vs. a Bare Metal Stent in Saphenous Vein Graft Lesions |
Estimated Enrollment: | 80 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | October 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Express 2 bare metal stent
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Device: Express 2 bare metal stent
Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
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2: Experimental
Taxus, paclitaxel-eluting stent
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Device: Taxus polymer-based paclitaxel-eluting stent
Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
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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 arterial conduits, saphenous vein grafts (SVGs) have a high rate of failure, requiring percutaneous coronary intervention (PCI) or repeat CABG. Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis. However, even with the use of bare metal stents, restenosis still occurs in 37-53% of the SVGs, often requiring repeat target vein graft revascularization.
Drug-eluting stents (DES) have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries. Even though, no randomized controlled trials have compared DES with bare stents in SVG interventions, DES are increasingly being used off label in this setting, based on registry data. DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries. We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent (which is identical to the paclitaxel-eluting stent but has no drug coating) in saphenous vein graft lesions.
Hypothesis: Compared to implantation of a bare metal stent, implantation of a similar paclitaxel-eluting stent (Taxus™, Boston Scientific, Nattick, Massachusetts) in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months.
Specific objectives: We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent (Taxus™) in order to determine:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Iowa | |
VA Iowa City Healthcare system | |
Iowa City, Iowa, United States, 52246 | |
United States, Texas | |
VA North Texas Health Care System | |
Dallas, Texas, United States, 75216 | |
Michael E. Debakey VA Medical Center | |
Houston, Texas, United States, 77030 | |
Greece | |
Onassis Cardiac Surgery Center | |
Athens, Greece, 17674 |
Principal Investigator: | Emmanouil S Brilakis, MD, PhD | VA North Texas Health Care System, University of Texas Southwestern Medical School |
Responsible Party: | VA North Texas Healthcare System ( Emmanouil Brilakis, MD, PhD ) |
Study ID Numbers: | VISN 17, 10N17 |
Study First Received: | October 31, 2005 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00247208 History of Changes |
Health Authority: | United States: Federal Government |
Coronary artery bypass Stents Angioplasty, Transluminal, Percutaneous Coronary Coronary Restenosis Paclitaxel |
Arterial Occlusive Diseases Paclitaxel Tubulin Modulators Vascular Diseases |
Antimitotic Agents Arteriosclerosis Antineoplastic Agents, Phytogenic Coronary Restenosis |
Arterial Occlusive Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vascular Diseases Arteriosclerosis Antimitotic Agents |
Pharmacologic Actions Paclitaxel Therapeutic Uses Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic |