The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
NCT ID: NCT01368627
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1274 participants
INTERVENTIONAL
2008-01-31
2011-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Supralimus® Sirolimus-Eluting Coronary Stent
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 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.
2. 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:
1. CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy \<12 months; impossibility to comply with all protocol follow-ups.
2. ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
18 Years
ALL
No
Sponsors
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Cardiovascular Research Center, Brazil
OTHER
Sahajanand Medical Technologies Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandre Abizaid,, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
Locations
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CIAS- Unimed Vitória
Vitória, Espírito Santo, Brazil
Centro de Cardiologia e Radiologia
Goiânia, Goiás, Brazil
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, Brazil
Hospital Monte Sinai
Juiz de Fora, Minas Gerais, Brazil
Hospital Vita
Curitiba, Paraná, Brazil
H.C.Unesp
Botucatu, São Paulo, Brazil
Hospital São Camilo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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Version 2.0
Identifier Type: -
Identifier Source: org_study_id