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XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study (XIENCE V India)

13. august 2012 opdateret af: Abbott Medical Devices

XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study

XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1000

Kontakter og lokationer

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

Studiesteder

  • Indien
      • Ahmedabad, Indien, 380054
        • Sal Hospital and Medical Institute
      • Amritsar, Indien
        • Escorts Heart & Superspeciality Institute Ltd.
      • Chennai, Indien, 600 037
        • Madras Medical Mission
      • Cochin, Indien
        • Lisie Heart Institute,Lisie Hosp.
      • Hyderabad, Indien, 500033
        • Apollo Hospital
      • Jaipur, Indien
        • Heart & General Hospital
      • Mumbai, Indien, 400050
        • Holy Family Hospital
      • New Delhi, Indien, 110025
        • Escorts Heart Institute & Research Centre
      • New Delhi, Indien, 110017
        • Max Devki Devi Heart & Vascular Institute
      • New Delhi, Indien, 110 070
        • Escorts Heart Institute & Research Centre
      • New Delhi, Indien, 110 070
        • Fortis Hospital
      • Pune, Indien, 411030
        • Poona hospital and research centre
      • Pune, Indien, 411001
        • Jehangir Hospital
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, Indien, 500034
        • Care Hospital
      • Hyderabad, Andhra Pradesh, Indien, 5000003
        • Krishna Heart Institute,
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380 006
        • Krishna Heart Institute
    • Punjab
      • Ludhiana, Punjab, Indien, 141001
        • Dayanand Medical College & Hospital
    • Tamilnadu
      • Vellore, Tamilnadu, Indien, 632004
        • Christian Medical Center (CMC)

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The group will be all consecutively enrolled patients in India treated by a broad group of physicians at a variety of health care facilities, who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Beskrivelse

Inclusion Criteria:

  • The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

  • The inability to obtain an informed consent is an exclusion criterion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Enhed: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
Andre navne:
  • XIENCE V® Everolimus Eluerende Coronary Stent System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Stent thrombosis rates as defined by Academic Research Consortium (ARC)
Tidsramme: Annually through to 3 years
Annually through to 3 years
Composite endpoint of cardiac death and myocardial infarction (MI)
Tidsramme: at 1 year
at 1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
Tidsramme: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Composite rate of all death and any MI (Q-wave and non Q-wave)
Tidsramme: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)
Tidsramme: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Death (cardiac death, vascular death, and non-cardiovascular death)
Tidsramme: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Any MI (Q-wave and non Q-wave)
Tidsramme: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Major bleeding complications
Tidsramme: at 14, 30, 180 days and at 1, 2 and 3 years
at 14, 30, 180 days and at 1, 2 and 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Tidsramme: at 14, 30, 180 days and at 1, 2 and 3 years
at 14, 30, 180 days and at 1, 2 and 3 years
Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
Tidsramme: at 30, 180 days and at 1, 2 and 3 years
at 30, 180 days and at 1, 2 and 3 years
Clinical device and procedural success
Tidsramme: Acute
Acute
Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
Tidsramme: at baseline, 180 days, and 1 year
at baseline, 180 days, and 1 year
Stent thrombosis
Tidsramme: 24 hours (acute) and 30 days (sub-acute)
24 hours (acute) and 30 days (sub-acute)
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
Tidsramme: 30, 180 days and 1, 2 and 3 years
30, 180 days and 1, 2 and 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Medical Devices

Efterforskere

  • Ledende efterforsker: Ashok Seth, MD, Max Devki Devi Heart & Vascular Institute
  • Ledende efterforsker: Tejas Patel, MD, Krishna Heart Institute

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. juni 2008

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

28. februar 2008

Først indsendt, der opfyldte QC-kriterier

6. marts 2008

Først opslået (Skøn)

7. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-378
  • REFCTRI000213, 21-10-2008 (Registry Identifier: Clinical Trials Registry - India)

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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