REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice (REPARA)
15. juli 2016 opdateret af: Sección Hemodinamica y Cardiologia Intervencionista
Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions.
A total of 1,500 patients are planned to be included in the registry.
Studieoversigt
Status
Ukendt
Detaljeret beskrivelse
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
Secondary objectives:
- Angina
- Death due to any cause.
- Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
- All TLR driven or not by ischaemia
- All TVR driven or not by ischaemia.
- All coronary revascularisations performed (PCI vs CABG)
- Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
- Immediate success of the device.
- Immediate success of the procedure.
- Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
- Composite endpoints:
Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))
- Rate of overlapping devices: characteristics and relationship with occurrence of events
- Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2440
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Madrid, Spanien, 28041
- Hospital 12 de Octubre
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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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with native coronary artery de novo lesions with indication for revascularization with a coronary device
Beskrivelse
Inclusion Criteria:
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
- The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter > 2 mm y < 3,8 mm.
- The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months
Exclusion Criteria:
- Cardiogenic shock
- Left main disease
- Aortocoronary graft
- Intrastent restenosis
- Potentially child-bearing women with no contraceptive methods
- Pregnant or breast-feeding women
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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BVS patients
Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
Tidsramme: Clinical follow-up at 12 months
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Clinical follow-up at 12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Immediate success of the device/procedure
Tidsramme: 1 day
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1 day
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Hjertedød
Tidsramme: 12 måneder
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12 måneder
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Myokardieinfarkt
Tidsramme: 12 måneder
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12 måneder
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Scaffold/Stent Thrombosis: Timing and Evidence
Tidsramme: 12 months
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12 months
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Target lesion/vessel revascularization (TLR/TVR)
Tidsramme: 12 months
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12 months
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Angina Events
Tidsramme: 12 months
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12 months
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Rate of patients with DAPT at 12 months
Tidsramme: 12 months
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12 months
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Rate of overlapping devices and characteristics
Tidsramme: 12 months
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Felipe Hernandez, MD, Seccion Hemodinamica y Cardiologia Intervencionista
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. januar 2014
Primær færdiggørelse (Faktiske)
1. september 2015
Studieafslutning (Forventet)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
23. september 2014
Først indsendt, der opfyldte QC-kriterier
30. september 2014
Først opslået (Skøn)
3. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- COR-BVS-2013-01
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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