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TAXUS PERSEUS Workhorse (PERSEUS WH)

24 aprile 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1264

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TAXUS Element
Dispositivo: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
Comparatore attivo: TAXUS Express
Dispositivo: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boston Scientific Corporation

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2007

Completamento primario (Effettivo)

1 settembre 2009

Completamento dello studio (Effettivo)

1 ottobre 2013

Date di iscrizione allo studio

Primo inviato

6 giugno 2007

Primo inviato che soddisfa i criteri di controllo qualità

6 giugno 2007

Primo Inserito (Stima)

8 giugno 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

8 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S2037
  • S2037-PIVOT-2006

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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