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
1 other identifier
interventional
1,274
1 country
7
Brief Summary
E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Jan 2008
Typical duration for phase_4 coronary-artery-disease
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 23, 2012
August 1, 2012
3.9 years
June 7, 2011
August 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MAJOR ADVERSE CARDIAC EVENTS (MACE)
12 months
Secondary Outcomes (4)
Rates of procedural success
24 month
Rates of Major Adverse Cardiac Event (MACE)
In-hospital, 30 days, 6 and 24 months
Rates of target lesion revascularization (TLR)
6 and 12 months
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Up to 24 months follow-up
Study Arms (1)
Supralimus® Sirolimus-Eluting Coronary Stent
EXPERIMENTALInterventions
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CIAS- Unimed Vitória
Vitória, Espírito Santo, 29047-575, Brazil
Centro de Cardiologia e Radiologia
Goiânia, Goiás, 74823-320, Brazil
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, 30380-090, Brazil
Hospital Monte Sinai
Juiz de Fora, Minas Gerais, 36025-550, Brazil
Hospital Vita
Curitiba, Paraná, Brazil
H.C.Unesp
Botucatu, São Paulo, Brazil
Hospital São Camilo
São Paulo, São Paulo, 05022-001, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Abizaid,, MD
Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 8, 2011
Study Start
January 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 23, 2012
Record last verified: 2012-08