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The SOS (Stenting Of Saphenous Vein Grafts) Trial

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ClinicalTrials.gov Identifier: NCT00247208
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : April 26, 2012
Sponsor:
Collaborators:
Clark R. Gregg Fund, Harris Methodist Foundation
University of Arkansas
US Department of Veterans Affairs
Michael Debakey Veterans Affairs Medical Center
Southern Arizona VA Health Care System
Onassis Cardiac Surgery Centre
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System

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 months when compared to a similar bare metal stent.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Arteriosclerosis Device: Taxus polymer-based paclitaxel-eluting stent Device: Express 2 bare metal stent Phase 3

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 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:

  1. whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and
  2. whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization, target vessel failure, overall major adverse cardiac and cerebrovascular events, and intra-stent intimal hyperplasia accumulation, as measured by intravascular ultrasound (secondary endpoints).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: 1
Express 2 bare metal stent
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.

Experimental: 2
Taxus, paclitaxel-eluting stent
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.
Other Name: Taxus drug-eluting stents




Primary Outcome Measures :
  1. binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. intrastent intimal hyperplasia accumulation as measured by IVUS [ Time Frame: 12 months for IVUS and 24 months for clinical follow-up ]
  2. incidence of ischemia-driven target vessel revascularization, target vessel failure, and overall major adverse cardiac and cerebrovascular events at 24-month follow-up [ Time Frame: 12 months for IVUS and 24 months for clinical follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247208


Locations
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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
Sponsors and Collaborators
North Texas Veterans Healthcare System
Clark R. Gregg Fund, Harris Methodist Foundation
University of Arkansas
US Department of Veterans Affairs
Michael Debakey Veterans Affairs Medical Center
Southern Arizona VA Health Care System
Onassis Cardiac Surgery Centre
Investigators
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Principal Investigator: Emmanouil S Brilakis, MD, PhD VA North Texas Health Care System, University of Texas Southwestern Medical School

Additional Information:
Publications of Results:

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Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, VA North Texas Healthcare System, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT00247208     History of Changes
Other Study ID Numbers: VISN 17, 10N17
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012
Keywords provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:
Coronary artery bypass
Stents
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis
Paclitaxel
Additional relevant MeSH terms:
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Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action