TAXUS PERSEUS Workhorse (PERSEUS WH)
24 de abril de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
1264
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital, Adelaide, SA, Australia
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Fitzroy, Victoria, Australia, 3065
- St. Vincents Public,
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Alabama
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Birmingham, Alabama, Estados Unidos, 35211
- Baptist Medical Center Princeton
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Birmingham, Alabama, Estados Unidos, 35235-3401
- Medical Center East
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California
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Bakersfield, California, Estados Unidos, 93301
- Bakersfield Memorial Hospital
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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La Jolla, California, Estados Unidos, 92037
- Scripps Memorial Hospital
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La Jolla, California, Estados Unidos, 92037
- Alvarado Hospital
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Sacramento, California, Estados Unidos, 95819
- Mercy General Hospital
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Sacramento, California, Estados Unidos, 95817
- University of California, Davis Medical Center
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Colorado
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Littleton, Colorado, Estados Unidos, 80120
- South Denver Cardiology Associates, PC
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Delaware
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Newark, Delaware, Estados Unidos, 19718-0002
- Christiana Hospital
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-3017
- Washington Hospital Center
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Florida
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Ocala, Florida, Estados Unidos, 34471
- MediQuest Research at Munroe Regional Medical Center
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Orlando, Florida, Estados Unidos, 32803
- Florida Hospital
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Sarasota, Florida, Estados Unidos, 34239-2940
- Sarasota Memorial Hospital
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Tallahassee, Florida, Estados Unidos, 32308
- Tallahassee Memorial Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
- Piedmont Hospital
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Atlanta, Georgia, Estados Unidos, 30342
- St. Joseph's Hospital of Atlanta
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Macon, Georgia, Estados Unidos, 31208
- Medical Center of Central Georgia
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96817
- Kaiser Foundation Hospitals
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Northwestern
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Rockford, Illinois, Estados Unidos, 61107
- St. Anthony's Medical Center
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Springfield, Illinois, Estados Unidos, 62701
- St. John's Hospital
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804-4140
- Northern Indiana Research Alliance / Lutheran Hospital of Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Krannert Institute of Cardiology
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Indianapolis, Indiana, Estados Unidos, 46290
- St. Vincent's Hospital
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Iowa
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Davenport, Iowa, Estados Unidos, 52803
- Trinity Terrace Park
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Des Moines, Iowa, Estados Unidos, 50134
- Iowa Heart Center
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Maine
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Portland, Maine, Estados Unidos, 04102-3134
- Maine Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218-2829
- Union Memorial Hospital
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Takoma Park, Maryland, Estados Unidos, 20912-6367
- Washington Adventist Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
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Boston, Massachusetts, Estados Unidos, 02115
- Beth Israel Deaconess Medical Center
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Hyannis, Massachusetts, Estados Unidos, 02601
- Cape Cod Research Institute
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Michigan
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Grand Blanc, Michigan, Estados Unidos, 48439
- Genesys Regional Medical Center
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Petoskey, Michigan, Estados Unidos, 49770
- Cardiac and Vascular Research Center of Northern Michigan
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St. Joseph, Michigan, Estados Unidos, 49085-2112
- Lakeland Hospitals at St. Joseph
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's Duluth Clinic Regional Heart Center
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Minneapolis, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Minneapolis, Minnesota, Estados Unidos, 55407-1195
- Abbott Northwestern Hospital
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Mississippi
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Tupelo, Mississippi, Estados Unidos, 38801
- North Mississippi Medical Center
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Missouri
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St. Louis, Missouri, Estados Unidos, 63128-2106
- St. Anthony's Medical Center
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68526
- Nebraska Heart Hospital
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Heart Hospital of New Mexico
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New York
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Liverpool, New York, Estados Unidos, 13088
- St. Joseph's Hospital Health Center
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10021
- Lenox Hill Hospital
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203-5866
- Carolinas Medical Center
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Greensboro, North Carolina, Estados Unidos, 27401
- LeBauer Cardiovascular Research Foundation
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Raleigh, North Carolina, Estados Unidos, 27610
- Wake Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Forsyth Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-0001
- Wake Forest University School of Medicine
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- The Christ Hospital
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Medical Center
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Columbus, Ohio, Estados Unidos, 43214-3907
- Riverside Methodist Hospital
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Oklahoma Foundation for Cardiovascular Research
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- Providence St. Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Hospital
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Bryn Mawr, Pennsylvania, Estados Unidos, 19010
- Main Line Health Heart Center
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Lancaster, Pennsylvania, Estados Unidos, 17604
- Lancaster General Hospital
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Langhorne, Pennsylvania, Estados Unidos, 19047
- St. Mary Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Medical Center
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29204-1018
- Sisters of Charity Providence Hospital
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Greenville, South Carolina, Estados Unidos, 29605
- University Medical Center-Greenville Memorial Hospital
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660-3831
- Wellmont Holston Valley Medical Center
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Nashville, Tennessee, Estados Unidos, 37232-7235
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75226
- Baylor Heart & Vascular Hospital
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Houston, Texas, Estados Unidos, 77030-2767
- Methodist DeBakey Heart Center
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San Antonio, Texas, Estados Unidos, 78229
- TexSAn Heart Hospital
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Tyler, Texas, Estados Unidos, 75701
- Trinity Mother Frances Health System
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042
- Inova Fairfax Hospital
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Lynchburg, Virginia, Estados Unidos, 24501
- Lynchburg General Hospital
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Norfolk, Virginia, Estados Unidos, 23507-1904
- Sentara Norfolk General Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center
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Spokane, Washington, Estados Unidos, 99204
- Deaconess Medical Center
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Spokane, Washington, Estados Unidos, 99204
- Sacred Heart Medical Center
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- St. Mary's Medical Center
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Aurora St. Luke's Medical Center
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Wausau, Wisconsin, Estados Unidos, 54401
- CaRE Foundation, Inc.
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Auckland, Nueva Zelanda, 1023
- Auckland City Hospital
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Christchurch, Nueva Zelanda, 8001
- Christchurch Hospital
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Hamilton, Nueva Zelanda, 3240
- Waikato Hospital
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Wellington, Nueva Zelanda
- Wellington Hospital
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Singapore, Singapur, 168752
- National Heart Centre
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: TAXUS Element
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TAXUS Element stent placement
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Comparador activo: TAXUS Express
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TAXUS Express Stent Implant
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 12 months post-index procedure
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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.
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12 months post-index procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Periodo de tiempo: 9 months post-index procedure
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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.
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9 months post-index procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dean J Kereiakes, MD, The Christ Hospital
- Investigador principal: Louis A Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de septiembre de 2009
Finalización del estudio (Actual)
1 de octubre de 2013
Fechas de registro del estudio
Enviado por primera vez
6 de junio de 2007
Primero enviado que cumplió con los criterios de control de calidad
6 de junio de 2007
Publicado por primera vez (Estimar)
8 de junio de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Enfermedad de la arteria coronaria
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Paclitaxel
- Paclitaxel unido a albúmina
Otros números de identificación del estudio
- S2037
- S2037-PIVOT-2006
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
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Boston Scientific CorporationTerminado