The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.
For this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.
All subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator's discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.
All patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
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São Paulo, Brasilien, 05022-001
- Hospital São Camilo
-
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Espírito Santo
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Vitória, Espírito Santo, Brasilien, 29047-575
- CIAS- Unimed Vitória
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Goiás
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Goiânia, Goiás, Brasilien, 74823-320
- Centro de Cardiologia e Radiologia
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-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30380-090
- Hospital Luxemburgo
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Juiz de Fora, Minas Gerais, Brasilien, 36025-550
- Hospital Monte Sinai
-
-
Paraná
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Curitiba, Paraná, Brasilien
- Hospital Vita
-
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Sao Paulo
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Botucatu, Sao Paulo, Brasilien
- H.C.Unesp
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- CLINICAL INCLUSION CRITERIA: Patients >18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.
- ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.
Exclusion Criteria:
- CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
- ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Supralimus® Sirolimus-Eluting Coronary Stent
|
Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rates of procedural success
Tidsram: 24 month
|
24 month
|
|
Rates of Major Adverse Cardiac Event (MACE)
Tidsram: In-hospital, 30 days, 6 and 24 months
|
In-hospital, 30 days, 6 and 24 months
|
|
Rates of target lesion revascularization (TLR)
Tidsram: 6 and 12 months
|
6 and 12 months
|
|
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Tidsram: Up to 24 months follow-up
|
Up to 24 months follow-up
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Alexandre Abizaid,, MD, Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Kranskärlssjukdom
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Sirolimus
Andra studie-ID-nummer
- Version 2.0 (Sponsor)
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