TAXUS PERSEUS Workhorse (PERSEUS WH)

April 24, 2014 updated by: Boston Scientific Corporation

A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions

The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries of 2.75 mm to 4.0 mm diameter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries ≥ 2.75 mm and ≤ 4.0 mm in diameter, compared to a control group of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System .

One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).

Eligible subjects will have annual follow-up until 5 years post-index procedure.

Study Type

Interventional

Enrollment (Actual)

1264

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

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital, Adelaide, SA, Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincents Public,
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Christchurch, New Zealand, 8001
        • Christchurch Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Wellington, New Zealand
        • Wellington Hospital
  • Singapore
      • Singapore, Singapore, 168752
        • National Heart Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
      • Birmingham, Alabama, United States, 35235-3401
        • Medical Center East
    • California
      • Bakersfield, California, United States, 93301
        • Bakersfield Memorial Hospital
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • La Jolla, California, United States, 92037
        • Alvarado Hospital
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates, PC
    • Delaware
      • Newark, Delaware, United States, 19718-0002
        • Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-3017
        • Washington Hospital Center
    • Florida
      • Ocala, Florida, United States, 34471
        • MediQuest Research at Munroe Regional Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Sarasota, Florida, United States, 34239-2940
        • Sarasota Memorial Hospital
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital of Atlanta
      • Macon, Georgia, United States, 31208
        • Medical Center of Central Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kaiser Foundation Hospitals
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern
      • Rockford, Illinois, United States, 61107
        • St. Anthony's Medical Center
      • Springfield, Illinois, United States, 62701
        • St. John's Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804-4140
        • Northern Indiana Research Alliance / Lutheran Hospital of Indiana
      • Indianapolis, Indiana, United States, 46202
        • Krannert Institute of Cardiology
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent's Hospital
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Trinity Terrace Park
      • Des Moines, Iowa, United States, 50134
        • Iowa Heart Center
    • Maine
      • Portland, Maine, United States, 04102-3134
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218-2829
        • Union Memorial Hospital
      • Takoma Park, Maryland, United States, 20912-6367
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Research Institute
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Petoskey, Michigan, United States, 49770
        • Cardiac and Vascular Research Center of Northern Michigan
      • St. Joseph, Michigan, United States, 49085-2112
        • Lakeland Hospitals at St. Joseph
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic Regional Heart Center
      • Minneapolis, Minnesota, United States, 55433
        • Mercy Hospital
      • Minneapolis, Minnesota, United States, 55407-1195
        • Abbott Northwestern Hospital
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63128-2106
        • St. Anthony's Medical Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Heart Hospital of New Mexico
    • New York
      • Liverpool, New York, United States, 13088
        • St. Joseph's Hospital Health Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203-5866
        • Carolinas Medical Center
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Columbus, Ohio, United States, 43214-3907
        • Riverside Methodist Hospital
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • LeHigh Valley Hospital
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Health Heart Center
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204-1018
        • Sisters of Charity Providence Hospital
      • Greenville, South Carolina, United States, 29605
        • University Medical Center-Greenville Memorial Hospital
    • Tennessee
      • Kingsport, Tennessee, United States, 37660-3831
        • Wellmont Holston Valley Medical Center
      • Nashville, Tennessee, United States, 37232-7235
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart & Vascular Hospital
      • Houston, Texas, United States, 77030-2767
        • Methodist DeBakey Heart Center
      • San Antonio, Texas, United States, 78229
        • TexSAn Heart Hospital
      • Tyler, Texas, United States, 75701
        • Trinity Mother Frances Health System
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • INOVA Fairfax Hospital
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg General Hospital
      • Norfolk, Virginia, United States, 23507-1904
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Spokane, Washington, United States, 99204
        • Deaconess Medical Center
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center
      • Wausau, Wisconsin, United States, 54401
        • CaRE Foundation, Inc.

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

Clinical Inclusion Criteria:

  • Subject is ≥ 18 years old
  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • Acceptable candidate for coronary artery bypass grafting (CABG)
  • Left ventricular ejection fraction (LVEF) is ≥ 30%
  • Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  • Subject willing to comply with all specified follow-up evaluations

Clinical Exclusion Criteria:

  • Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine
  • Known hypersensitivity to paclitaxel
  • Known allergy to stainless steel
  • Known allergy to platinum
  • Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
  • Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
  • Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
  • Previous treatment with intravascular brachytherapy in the target vessel
  • Planned PCI or CABG post-index procedure
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
  • Myocardial infarction (MI) within 72 hours prior to index procedure
  • Cerebrovascular accident (CVA) within the past 6 months
  • Cardiogenic shock
  • Acute or chronic renal dysfunction
  • Prior anaphylactic reaction to contrast agents
  • Leukopenia
  • Thrombocytopenia
  • Thrombocytosis
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents
  • Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  • Known intention to procreate within 9 months after the index procedure
  • Positive pregnancy test within 7 days before the index procedure, or lactating
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity
  • Currently participating in another investigational drug or device study

Angiographic Inclusion Criteria:

  • Target Lesion

    • Target lesion located in native coronary artery
    • Target lesion must be de novo
    • Target lesion diameter stenosis ≥ 50%
    • Reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 4.0 mm
    • Cumulative target lesion length ≤ 28 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent)
    • Target lesion is successfully pre-dilated

  • One non-target lesion may be treated in a non-target vessel as follows:

    • Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required
    • Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s)
    • Treatment must be completed prior to treatment of target vessel

Angiographic Exclusion Criteria

  • Target lesion located in left main artery, whether protected or unprotected
  • Target lesion is a chronic total occlusion (TIMI flow ≤ 1)
  • Target lesion is restenotic
  • Target lesion is located in a saphenous vein graft or mammary artery graft
  • Target lesion is accessed via saphenous vein graft or mammary artery graft
  • Target lesion is < 5 mm from bare metal stent (BMS)
  • Target lesion < 5 mm from ostium
  • Target lesion < 5 mm from side branch vessel ≥ 2.0 mm in diameter (Exceptions: subject may be enrolled if side branch is 100% occluded or if side branch is protected with a patent graft)
  • Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel at a location with ≥ 2.0mm RVD
  • Target lesion and/or target vessel proximal to target lesion moderately or severely calcified
  • Target lesion and/or target vessel proximal to target lesion severely tortuous
  • Target lesion located within or distal to a > 60° bend in target vessel
  • Target vessel with angiographic presence of probable or definite thrombus
  • Unprotected left main coronary artery disease
  • Protected left main coronary artery disease with target lesion in Left Anterior Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if only lesion is target lesion in Right Coronary Artery (RCA)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAXUS Element
Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
Active Comparator: TAXUS Express
Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.
Time Frame: 12 months post-index procedure
The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.
12 months post-index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Time Frame: 9 months post-index procedure
The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.
9 months post-index procedure

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital
  • Principal Investigator: Louis A Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan

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

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

July 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2037
  • S2037-PIVOT-2006

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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