The SOS (Stenting Of Saphenous Vein Grafts) Trial

April 25, 2012 updated by: Emmanouil Brilakis, North Texas Veterans Healthcare System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17674
        • Onassis Cardiac Surgery Center
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • VA Iowa City Healthcare system
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Taxus drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
intrastent intimal hyperplasia accumulation as measured by IVUS
Time Frame: 12 months for IVUS and 24 months for clinical follow-up
12 months for IVUS and 24 months for clinical follow-up
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
12 months for IVUS and 24 months for clinical follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Collaborators

US Department of Veterans Affairs
University of Arkansas
Michael E. DeBakey VA Medical Center
Southern Arizona VA Health Care System
Clark R. Gregg Fund, Harris Methodist Foundation
Onassis Cardiac Surgery Centre

Investigators

  • Principal Investigator: Emmanouil S Brilakis, MD, PhD, VA North Texas Health Care System, University of Texas Southwestern Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISN 17, 10N17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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