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Coronary Artery DiseasePhase 3PERSEUS WHNCT00484315

TAXUS PERSEUS Workhorse

A Phase 3 study testing Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation and Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement in people with Coronary Artery Disease, run by Boston Scientific Corporation at 90 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation and Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,264 participants
Where
90 sitesin 4 countries
Study dates
Jul 2007to Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

90 sites in 4 countries.

90 sites in 4 countries

United States82 sites

  • Heart Hospital of New Mexico

    Albuquerque, New Mexico, 87102

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • St. Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Bakersfield Memorial Hospital

    Bakersfield, California, 93301

  • Union Memorial Hospital

    Baltimore, Maryland, 21218-2829

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211

  • Medical Center East

    Birmingham, Alabama, 35235-3401

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Main Line Health Heart Center

    Bryn Mawr, Pennsylvania, 19010

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203-5866

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Sisters of Charity Providence Hospital

    Columbia, South Carolina, 29204-1018

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214-3907

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Trinity Terrace Park

    Davenport, Iowa, 52803

  • Iowa Heart Center

    Des Moines, Iowa, 50134

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota, 55805

  • Evanston Northwestern

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Northern Indiana Research Alliance / Lutheran Hospital of Indiana

    Fort Wayne, Indiana, 46804-4140

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • University Medical Center-Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Kaiser Foundation Hospitals

    Honolulu, Hawaii, 96817

  • Methodist DeBakey Heart Center

    Houston, Texas, 77030-2767

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Krannert Institute of Cardiology

    Indianapolis, Indiana, 46202

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46290

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660-3831

  • Alvarado Hospital

    La Jolla, California, 92037

  • Scripps Clinic

    La Jolla, California, 92037

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • St. Joseph's Hospital Health Center

    Liverpool, New York, 13088

  • Lynchburg General Hospital

    Lynchburg, Virginia, 24501

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407-1195

  • Mercy Hospital

    Minneapolis, Minnesota, 55433

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-7235

  • Lenox Hill Hospital

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19718-0002

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507-1904

  • Mediquest Research at Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Cardiac and Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Maine Medical Center

    Portland, Maine, 04102-3134

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • St. Anthony's Medical Center

    Rockford, Illinois, 61107

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • Lakeland Hospitals at St. Joseph

    Saint Joseph, Michigan, 49085-2112

  • TexSAn Heart Hospital

    San Antonio, Texas, 78229

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239-2940

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • St. John's Hospital

    Springfield, Illinois, 62701

  • St. Anthony's Medical Center

    St Louis, Missouri, 63128-2106

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912-6367

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Trinity Mother Frances Health System

    Tyler, Texas, 75701

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010-3017

  • CaRE Foundation, Inc.

    Wausau, Wisconsin, 54401

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

New Zealand4 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, 8001

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Wellington

Other trials in New Zealand

Australia3 sites

  • Royal Adelaide Hospital, Adelaide, SA, Australia

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincents Public,

    Fitzroy, Victoria, 3065

Other trials in Australia

Singapore1 site

  • National Heart Centre

    Singapore, 168752

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation, Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
Keywords
drug-eluting stent, paclitaxel-eluting stent, DES
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantationDevice

    TAXUS Element stent placement

  • Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placementDevice

    TAXUS Express Stent Implant

Study groups in NCT00484315
Study groupRoleWhat they receive
TAXUS ElementExperimentalNot described
Receives: Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS ExpressActive comparatorNot described
Receives: Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 12 months post-index procedure

Secondary outcomes (1)

  1. In-segment Percent Diameter Stenosis at 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.

    Measured: 9 months post-index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionSep 2009
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484315
Sponsor's protocol ID
S2037
Other IDs
S2037-PIVOT-2006
Acronym
PERSEUS WH
Status last verified
Apr 2014
First submitted
6 Jun 2007
Last updated
8 May 2014
Data monitoring committee
Yes

Publications

  • Kereiakes DJ, Cannon LA, Feldman RL, Popma JJ, Magorien R, Whitbourn R, Dauber IM, Rabinowitz AC, Ball MW, Bertolet B, Kabour A, Foster MC, Wang JC, Underwood P, Dawkins KD. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):264-71. doi: 10.1016/j.jacc.2010.04.011. Epub 2010 May 20.

    PubMed 20493653

  • Allocco DJ, Cannon LA, Britt A, Heil JE, Nersesov A, Wehrenberg S, Dawkins KD, Kereiakes DJ. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials. 2010 Jan 7;11:1. doi: 10.1186/1745-6215-11-1.

    PubMed 20059766

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation and Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement in people with Coronary Artery Disease, run by Boston Scientific Corporation at 90 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, New Zealand, Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00484315, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.

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TAXUS PERSEUS Workhorse (NCT00484315) | AzTrials