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- Register voor klinische proeven in de VS.
- Klinische proef NCT02029092
BIOFLOW III Satellite-ELADIS Orsiro Stent System
BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Badajoz, Spanje
- Hospital Infanta Cristina
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Barcelona, Spanje
- Hospital Vall d' Hebron
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Cadiz, Spanje
- Hospital G.de Jerez de la Frontera
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Gasteiz / Vitoria, Spanje
- Hospital de Txagorritxu
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Murcia, Spanje
- Hospital Univ. Virgen de la Arrixaca
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Mérida, Spanje
- Hospital de Mérida
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Sabadell, Spanje
- Hospital Parc Tauli
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Santiago de Compostela, Spanje, 15702
- Complejo de Hospitalario de Santiago
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Sevilla, Spanje
- Hospital Virgen Del Rocio
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Terrassa, Spanje
- Hospital Mutua de Terrassa
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Valencia, Spanje
- Hospital Clinico de Valencia
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Valencia, Spanje
- Hospital Doctor Peset
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Vizcaya, Spanje, 48903
- Hospital de Cruces
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A/Altos de Nava s/n
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León, A/Altos de Nava s/n, Spanje, 24080
- Hospital Universitario León
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Symptomatic coronary artery disease
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is≥18 years of age.
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 or contrast media.
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not yet reached.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Orsiro
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Doellaesiefalen (TLF)
Tijdsspanne: 12 maanden
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Samenstelling van hartdood, doelbloedvat Q-golf of niet-Q-golf myocardinfarct (MI), coronaire bypass-transplantaat (CABG) en klinisch gestuurde doellaesie-revascularisatie (TLR).
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12 maanden
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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TLF
Tijdsspanne: 6 months
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Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
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6 months
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Target Vessel Revascularization (TVR)
Tijdsspanne: 6 and 12 months
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Target Vessel Revascularization (TVR)
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6 and 12 months
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Target lesion revascularization (TLR)
Tijdsspanne: 6 and 12 months
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Target lesion revascularization (TLR)
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6 and 12 months
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Stent Thrombosis rate
Tijdsspanne: 6 and 12 months
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Stent Thrombosis rate
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6 and 12 months
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Device success
Tijdsspanne: up to discharge
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
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up to discharge
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Procedure success
Tijdsspanne: up to 7 days after procedure
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
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up to 7 days after procedure
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Sonia Martin, CEM BIOTRONIK SA
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- STEMI
- Angina
- Ischemie
- Internationale
- NSTEMI
- Multicenter
- Percutane coronaire interventie (PCI)
- Observationeel register
- Orsiro medicijnafgevende stent (DES)
- Stenten
- Coronaire revascularisatie
- Kleine schepen
- Behandeling van coronaire hartziekte
- Acuut myocardinfarct (AMI)
- Chronical Total Occlusion (CTO)
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- G1302
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Coronaire hartziekte
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Deutsches Herzzentrum MuenchenVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftDuitsland
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University Hospital, AngersWervingPopliteale slagaderbeknellingFrankrijk
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University Hospital, AngersVoltooidPoplitea Entrapment SyndroomFrankrijk
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Stanford UniversityIngetrokkenPoplitea Artery Entrapment Syndroom | Functioneel beknellingssyndroom van de arteria popliteaVerenigde Staten
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University Hospital, Strasbourg, FranceWervingEpistaxis, Anterior Ethmoid ArteryFrankrijk
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Resicardunion nationale de formation et d'evaluation en medecine cardio-vasculaireVoltooidHartfalen | Acute kransslagader syndroom | Coronaire Bypass Graft Stenose van Native Artery GraftFrankrijk