- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01880242
BIOFLOW-III Canada Satellite Registry
19. september 2017 opdateret af: Biotronik Canada Inc
Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success.
However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing.
The reported incidence of restenosis after PTCA ranges from 30%-50%.
Such rates of recurrence have serious economic consequences.
Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.
BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia.
The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.
These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
250
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Toronto, Canada, M5B1WG8
- St. Michael's Hospital
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Quebec
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Montréal, Quebec, Canada, H2W 1T8
- Centre Hospitalier de l'Université de Montréal (CHUM)
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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
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Beskrivelse
Inclusion Criteria:
- Symptomatic coronary artery disease or documented silent ischemia
- Subject informed consent for data release
- Subject is geographically stable and willing to participate at all follow ups assessments
Exclusion Criteria:
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation/antiplatelet therapy required for PCI, stainless steel, sirolimus
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
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 |
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Orsiro DES
Subjects requiring coronary revascularization with Drug Eluting Stents (DES). subgroups: Subjects presenting with
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Target Lesion Failure
Tidsramme: 12 months
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Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Stent trombose
Tidsramme: 6 og 12 måneder
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Konkret, sandsynlig og mulig stenttrombose
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6 og 12 måneder
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Target Lesion Failure
Tidsramme: 6 and 12 months
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Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
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6 and 12 months
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Target Vessel revascularization (TVR)
Tidsramme: 6 and 12 months
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Any repeat revascularization of the target vessel
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6 and 12 months
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Target Lesion Revascularization (TLR)
Tidsramme: 6 and 12 months
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Any repeat revascularization of the target lesion
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6 and 12 months
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Clinical Device Success
Tidsramme: 1 day (At time of intervention)
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Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.
Standard predilation catheters and post-dilation catheters (if applicable) may be used.
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1 day (At time of intervention)
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Clinical Procedure Success
Tidsramme: During the hospital stay to a maximum of the first seven days post index procedure
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Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
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During the hospital stay to a maximum of the first seven days post index procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Samer Mansour, Dr, MD, Centre Hospitalier de l'Université de Montréal (CHUM)
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 (Faktiske)
13. maj 2014
Primær færdiggørelse (Faktiske)
1. august 2017
Studieafslutning (Faktiske)
1. august 2017
Datoer for studieregistrering
Først indsendt
14. juni 2013
Først indsendt, der opfyldte QC-kriterier
17. juni 2013
Først opslået (Skøn)
18. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- G1207
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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