- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00484315
TAXUS PERSEUS Workhorse (PERSEUS WH)
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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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South Australia
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Adelaide, South Australia, Austrália, 5000
- Royal Adelaide Hospital, Adelaide, SA, Australia
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Victoria
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Clayton, Victoria, Austrália, 3168
- Monash Medical Centre
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Fitzroy, Victoria, Austrália, 3065
- St. Vincents Public,
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Singapore, Cingapura, 168752
- National Heart Centre
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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, Nova Zelândia, 1023
- Auckland City Hospital
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Christchurch, Nova Zelândia, 8001
- Christchurch Hospital
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Hamilton, Nova Zelândia, 3240
- Waikato Hospital
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Wellington, Nova Zelândia
- Wellington Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: TAXUS Element
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TAXUS Element stent placement
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Comparador Ativo: TAXUS Express
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TAXUS Express Stent Implant
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
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.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Prazo: 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
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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Isquemia do miocárdio
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças Vasculares
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doença cardíaca
- Doença arterial coronária
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Paclitaxel
- Paclitaxel ligado à albumina
Outros números de identificação do estudo
- S2037
- S2037-PIVOT-2006
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