- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368627
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05022-001
- Hospital São Camilo
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29047-575
- CIAS- Unimed Vitória
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Goiás
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Goiânia, Goiás, Brazil, 74823-320
- Centro de Cardiologia e Radiologia
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30380-090
- Hospital Luxemburgo
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Juiz de Fora, Minas Gerais, Brazil, 36025-550
- Hospital Monte Sinai
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Paraná
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Curitiba, Paraná, Brazil
- Hospital Vita
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Sao Paulo
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Botucatu, Sao Paulo, Brazil
- H.C.Unesp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supralimus® Sirolimus-Eluting Coronary Stent
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Time Frame: 12 months
|
12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of procedural success
Time Frame: 24 month
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24 month
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Rates of Major Adverse Cardiac Event (MACE)
Time Frame: In-hospital, 30 days, 6 and 24 months
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In-hospital, 30 days, 6 and 24 months
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Rates of target lesion revascularization (TLR)
Time Frame: 6 and 12 months
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6 and 12 months
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Rates of stent thrombosis (acute, sub-acute, late and very-late)
Time Frame: Up to 24 months follow-up
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Up to 24 months follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexandre Abizaid,, MD, Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- Version 2.0 (Sponsor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Supralimus® Sirolimus-Eluting Coronary Stent
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Sahajanand Medical Technologies Pvt. Ltd.Cardialysis BVTerminatedCoronary Artery DiseaseIndia, Brazil, Saudi Arabia
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Sahajanand Medical Technologies Pvt. Ltd.Completed
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Meril Life Sciences Pvt. Ltd.UnknownCoronary Artery DiseaseUnited Kingdom, Brazil, Spain, Macedonia, The Former Yugoslav Republic of, Belgium, Czechia, Latvia, Netherlands, Poland
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A.O. Ospedale Papa Giovanni XXIIIMedtronic; Case Western Reserve UniversityCompletedAcute Myocardial InfarctionItaly
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Medtronic VascularCompletedCoronary Artery Disease, Autosomal Dominant, 1United States
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Cordis CorporationTerminatedAtherosclerotic Coronary Artery DiseaseSpain, Switzerland, Netherlands
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Medtronic VascularMedtronic Japan Co., Ltd.CompletedMyocardial Ischemia | Cardiovascular Diseases | Coronary Artery Disease | Arterial Occlusive DiseasesJapan
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Paul S Teirstein, MDCordis CorporationCompletedCoronary Artery Disease | Coronary Thrombosis | Coronary RestenosisUnited States
-
Cook Group IncorporatedCompleted
-
Abbott Medical DevicesCompletedMyocardial Ischemia | Coronary Artery Disease | Stent Thrombosis | Vascular Disease | Coronary Artery Stenosis | Stents | Total Coronary Occlusion | Coronary Artery RestenosisUnited States