TAXUS PERSEUS Workhorse (PERSEUS WH)
24. april 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1264
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital, Adelaide, SA, Australia
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash Medical Centre
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Fitzroy, Victoria, Australien, 3065
- St. Vincents Public,
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Alabama
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Birmingham, Alabama, Forenede Stater, 35211
- Baptist Medical Center Princeton
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Birmingham, Alabama, Forenede Stater, 35235-3401
- Medical Center East
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California
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Bakersfield, California, Forenede Stater, 93301
- Bakersfield Memorial Hospital
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La Jolla, California, Forenede Stater, 92037
- Scripps Clinic
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La Jolla, California, Forenede Stater, 92037
- Scripps Memorial Hospital
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La Jolla, California, Forenede Stater, 92037
- Alvarado Hospital
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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Sacramento, California, Forenede Stater, 95817
- University of California, Davis Medical Center
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Colorado
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Littleton, Colorado, Forenede Stater, 80120
- South Denver Cardiology Associates, PC
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Delaware
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Newark, Delaware, Forenede Stater, 19718-0002
- Christiana Hospital
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-3017
- Washington Hospital Center
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Florida
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Ocala, Florida, Forenede Stater, 34471
- MediQuest Research at Munroe Regional Medical Center
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Orlando, Florida, Forenede Stater, 32803
- Florida Hospital
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Sarasota, Florida, Forenede Stater, 34239-2940
- Sarasota Memorial Hospital
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342
- St. Joseph's Hospital of Atlanta
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Macon, Georgia, Forenede Stater, 31208
- Medical Center of Central Georgia
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96817
- Kaiser Foundation Hospitals
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Illinois
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Evanston, Illinois, Forenede Stater, 60201
- Evanston Northwestern
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Rockford, Illinois, Forenede Stater, 61107
- St. Anthony's Medical Center
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Springfield, Illinois, Forenede Stater, 62701
- St. John's Hospital
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804-4140
- Northern Indiana Research Alliance / Lutheran Hospital of Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Krannert Institute of Cardiology
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Indianapolis, Indiana, Forenede Stater, 46290
- St. Vincent's Hospital
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Iowa
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Davenport, Iowa, Forenede Stater, 52803
- Trinity Terrace Park
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Des Moines, Iowa, Forenede Stater, 50134
- Iowa Heart Center
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Maine
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Portland, Maine, Forenede Stater, 04102-3134
- Maine Medical Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21218-2829
- Union Memorial Hospital
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Takoma Park, Maryland, Forenede Stater, 20912-6367
- Washington Adventist Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
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Boston, Massachusetts, Forenede Stater, 02115
- Beth Israel Deaconess Medical Center
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Research Institute
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Michigan
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Grand Blanc, Michigan, Forenede Stater, 48439
- Genesys Regional Medical Center
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Petoskey, Michigan, Forenede Stater, 49770
- Cardiac and Vascular Research Center of Northern Michigan
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St. Joseph, Michigan, Forenede Stater, 49085-2112
- Lakeland Hospitals at St. Joseph
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's Duluth Clinic Regional Heart Center
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Minneapolis, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Minneapolis, Minnesota, Forenede Stater, 55407-1195
- Abbott Northwestern Hospital
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Mississippi
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Tupelo, Mississippi, Forenede Stater, 38801
- North Mississippi Medical Center
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Missouri
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St. Louis, Missouri, Forenede Stater, 63128-2106
- St. Anthony's Medical Center
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68526
- Nebraska Heart Hospital
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Heart Hospital of New Mexico
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New York
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Liverpool, New York, Forenede Stater, 13088
- St. Joseph's Hospital Health Center
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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New York, New York, Forenede Stater, 10021
- Lenox Hill Hospital
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28203-5866
- Carolinas Medical Center
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Greensboro, North Carolina, Forenede Stater, 27401
- LeBauer Cardiovascular Research Foundation
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Raleigh, North Carolina, Forenede Stater, 27610
- Wake Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Forsyth Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27157-0001
- Wake Forest University School of Medicine
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- The Christ Hospital
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Medical Center
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Columbus, Ohio, Forenede Stater, 43214-3907
- Riverside Methodist Hospital
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Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Oklahoma Foundation for Cardiovascular Research
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- LeHigh Valley Hospital
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Main Line Health Heart Center
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
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Langhorne, Pennsylvania, Forenede Stater, 19047
- St. Mary Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Medical Center
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29204-1018
- Sisters of Charity Providence Hospital
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Greenville, South Carolina, Forenede Stater, 29605
- University Medical Center-Greenville Memorial Hospital
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37660-3831
- Wellmont Holston Valley Medical Center
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Nashville, Tennessee, Forenede Stater, 37232-7235
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75226
- Baylor Heart & Vascular Hospital
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Houston, Texas, Forenede Stater, 77030-2767
- Methodist DeBakey Heart Center
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San Antonio, Texas, Forenede Stater, 78229
- TexSAn Heart Hospital
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Tyler, Texas, Forenede Stater, 75701
- Trinity Mother Frances Health System
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care
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Virginia
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Falls Church, Virginia, Forenede Stater, 22042
- INOVA Fairfax Hospital
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Lynchburg, Virginia, Forenede Stater, 24501
- Lynchburg General Hospital
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Norfolk, Virginia, Forenede Stater, 23507-1904
- Sentara Norfolk General Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center
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Spokane, Washington, Forenede Stater, 99204
- Deaconess Medical Center
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Spokane, Washington, Forenede Stater, 99204
- Sacred Heart Medical Center
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- St. Mary's Medical Center
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53215
- Aurora St. Luke's Medical Center
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Wausau, Wisconsin, Forenede Stater, 54401
- CaRE Foundation, Inc.
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Christchurch, New Zealand, 8001
- Christchurch Hospital
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Hamilton, New Zealand, 3240
- Waikato Hospital
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Wellington, New Zealand
- Wellington Hospital
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Singapore, Singapore, 168752
- National Heart Centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: TAXUS Element
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TAXUS Element stent placement
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Aktiv komparator: TAXUS Express
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TAXUS Express Stent Implant
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
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12 months post-index procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Dean J Kereiakes, MD, The Christ Hospital
- Ledende efterforsker: Louis A Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
6. juni 2007
Først indsendt, der opfyldte QC-kriterier
6. juni 2007
Først opslået (Skøn)
8. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Koronararteriesygdom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Paclitaxel
- Albumin-bundet Paclitaxel
Andre undersøgelses-id-numre
- S2037
- S2037-PIVOT-2006
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .