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A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions

1. februar 2012 opdateret af: Boston Scientific Corporation

TAXUS ATLAS LONG LESION: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With Long de Novo Coronary Artery Lesions

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté 38 mm stent to an historical TAXUS Express control. The control group is a case-matched, blended, long lesion subset population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR 38 mm stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95819
        • Mercy General Hospital
    • Delaware
      • Newark, Delaware, Forenede Stater, 19718-0002
        • Christiana Hospital
    • Florida
      • Orlando, Florida, Forenede Stater, 32803
        • Florida Hospital
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62701
        • St. John's Hospital
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46290
        • The Heart Center
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Maine Medical Center
    • Maryland
      • Takoma Park, Maryland, Forenede Stater, 20912
        • Washington Adventist Hospital
    • Michigan
      • Petoskey, Michigan, Forenede Stater, 49770
        • Northern Michigan Hospital
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • St. Mary's Duluth Clinic Regional Heart Center
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • North Mississippi Medical Center
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27610
        • Wake Medical Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • North Ohio Research Elyria Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • The Pennsylvania State University Milton S Hershey Medical Center
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030-2767
        • Methodist DeBakey Heart Center
      • Temple, Texas, Forenede Stater, 76508
        • Scott & White Memorial Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Christchurch, New Zealand, 8001
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
    • Epsom
      • Auckland, Epsom, New Zealand, 1003
        • Mercy Angiography Unit, 98 Mountain Road, First Floor
  • Singapore
      • Singapore, Singapore
        • National University Hospital
      • Singapore, Singapore, 168752
        • National Heart Centre

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

General Inclusion Criteria:

  1. Patient is at least 18 years old.
  2. Eligible for percutaneous coronary intervention (PCI)
  3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia
  4. Left ventricular ejection fraction (LVEF) of at least 25%
  5. Acceptable candidate for coronary artery bypass grafting (CABG)
  6. Patient 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
  7. Willing to comply with all specified follow-up evaluations

Angiographic Inclusion Criteria:

  1. Only one lesion (target lesion) may be treated with the study stent.However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
  2. Successful predilation is mandatory for entry into study
  3. Target lesion located within a single native coronary artery
  4. Target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments) but must be completely covered by one study stent.
  5. Cumulative target lesion length is greater than or equal to 26 mm and less than or equal to 34 mm (visual estimate)
  6. Target lesion RVD is greater than or equal to 2.7 mm and less than or equal to 4.0 mm (visual estimate)
  7. Target lesion diameter stenosis at least 50% (visual estimate)
  8. Target lesion is de novo (i.e., a coronary lesion not previously treated)

General Exclusion Criteria:

  1. Known hypersensitivity to paclitaxel
  2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
  3. Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
  4. Previous or planned treatment with intravascular brachytherapy in the target vessel
  5. Planned CABG within 9-months post-index procedure
  6. MI within 72 hours prior to the index procedure and/or creatine kinase(CK) >2x the local laboratory's ULN unless CK-MB is <2x ULN
  7. Cerebrovascular Accident (CVA) within the past 6 months
  8. Cardiogenic Shock
  9. Acute or chronic renal dysfunction
  10. Contraindication to ASA, or to both clopidogrel and ticlopidine
  11. Leukopenia
  12. Thrombocytopenia or thrombocytosis
  13. Active peptic ulcer or active gastrointestinal (GI) bleeding
  14. Known allergy to stainless steel
  15. Any prior true anaphylactic reaction to contrast agents
  16. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
  17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  18. Male or female with known intention to procreate within 3 months after the index procedure
  19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
  20. Life expectancy of less than 24 months due to other medical condition
  21. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  22. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

Angiographic Exclusion Criteria:

  1. Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)
  2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
  3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
  4. Target lesion and/or target vessel proximal to the target lesion is tortuous
  5. Target lesion is located within or distal to a >60 degree bend in the vessel
  6. Target lesion involves a bifurcation with a side branch vessel >2.0mm in diameter
  7. Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation
  8. Angiographic presence of probable or definite thrombus
  9. Pre-treatment of the target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon.

  10. A previously treated lesion within the target vessel:

    • <15mm from the target lesion (visual estimate)
    • Performed </= 6 months from index procedure
    • >30% residual stenosis after previous treatment

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Enhed: TAXUS Liberté-SR
Paclitaxel-Eluting Coronary 38 mm Stent
Andet: Arm 2
Historical Comparator: control data derived from the TAXUS IV and TAXUS V clinical trials
Enhed: TAXUS™ Express
Paclitaxel-eluerende koronar stentsystem

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percent diameter stenosis of the analysis segment at 9-months
Tidsramme: 9 Months
9 Months

Sekundære resultatmål

Resultatmål
Tidsramme
Klinisk proceduremæssig og teknisk succes
Tidsramme: 5 år
5 år
Udnyttelsesparametre (udnyttelse af udstyr; katetre, guidewires og balloner, proceduretid, fluoroskopitid og mængden af ​​anvendt kontrast)
Tidsramme: 9 måneder
9 måneder
MACE-satser ved udskrivelse, 1, 4 og 9 måneder og 1, 2, 3, 4 og 5 år efter indeksprocedure.
Tidsramme: 5 år
5 år
Stent trombosehastighed
Tidsramme: 5 år
5 år
Target Vessel Failure (TVF)
Tidsramme: 5 år
5 år
Target Vessel Revaskularization (TVR)
Tidsramme: 5 år
5 år
QCA-parametre (binær restenoserate, in-stent %DS, MLD og sent tab)
Tidsramme: 9 måneder
9 måneder
IVUS parameters (percent net volume obstruction, incomplete apposition, stent areas and volume, vessel areas and volume, lumen areas and volume, neointimal area volume)
Tidsramme: 9 Months
9 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Scientific Corporation

Efterforskere

  • Studieleder: Peter Maurer, MPH, Boston Scientific Corporation
  • Ledende efterforsker: Mark A Turco, MD, Washington Adventist Hospital
  • Ledende efterforsker: John A Ormiston, MD, Mercy Hospital

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

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. marts 2005

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

1. september 2006

Først indsendt, der opfyldte QC-kriterier

1. september 2006

Først opslået (Skøn)

4. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S2039
  • TAXUS ATLAS Long Lesion

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 .

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