REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
1. mars 2017 oppdatert av: Hyeon-Cheol Gwon, Samsung Medical Center
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.
Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.
BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Forventet)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 135-710
- Rekruttering
- Cardiac and Vascular Center; Samsung Medical Center
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Ta kontakt med:
- Hyeon-Cheol Gwon, Professor
- Telefonnummer: 82234103419
- E-post: hc.gwon@samsung.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
A total of 1,000 patients derived from a population of Korean patients receiving PCI for coronary artery disease will be enrolled in the present registry.
It is recommended that each enrolling investigator review the most recent instructions for use (IFU) of Absorb™ and assess the contraindications, warnings, and precaution sections for treating potential patients.
Beskrivelse
Inclusion Criteria:
- Subject must be between 19 and 70 years old.
- Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
- Patients are scheduled for coronary intervention
- He/she or his/her legally authorized representative provides written informed consent
Exclusion Criteria:
- Experience of cardiopulmonary resuscitation
- Cardiogenic shock
- Expected survival less than 2 years
- Pregnancy or breast feeding
- Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Bioresorbable Scaffold
Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)
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The implantation procedure of an Absorb™ is similar to a metallic stent.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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cardiac death
Tidsramme: 2 years
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Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
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2 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Device success
Tidsramme: maximum of 7 days
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Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable).
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maximum of 7 days
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Procedural success
Tidsramme: maximum of 7 days
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Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat target lesion revascularization (TLR) during the hospital stay (maximum of 7 days).
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maximum of 7 days
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Target vessel failure (TVF)
Tidsramme: 1, 3, and 5 years
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cardiac death, target vessel MI, or TVR
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1, 3, and 5 years
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Each component of Target vessel failure (TVF)
Tidsramme: 1, 2, 3 and 5 years
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Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)
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1, 2, 3 and 5 years
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Target lesion failure
Tidsramme: 1, 2, 3 and 5 years
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Target lesion failure of cardiac death, MI attributed to the target vessel, and Target Lesion Revascularization(TLR). TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
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1, 2, 3 and 5 years
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Definite or probable stent thrombosis
Tidsramme: 1, 2, 3 and 5 years
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1, 2, 3 and 5 years
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Periprocedural enzyme elevation
Tidsramme: 1, 2, 3 and 5 years
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1, 2, 3 and 5 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2015
Primær fullføring (Forventet)
1. desember 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
5. november 2015
Først innsendt som oppfylte QC-kriteriene
8. november 2015
Først lagt ut (Anslag)
10. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2015-07-163
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