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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,274
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
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
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Time frame: 12 months
Rates of procedural success
Time frame: 24 month
Rates of Major Adverse Cardiac Event (MACE)
Time frame: In-hospital, 30 days, 6 and 24 months
Rates of target lesion revascularization (TLR)
Time frame: 6 and 12 months
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Time frame: Up to 24 months follow-up
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Hospital Vita
Curitiba, Paraná, Brazil
H.C.Unesp
Botucatu, São Paulo, Brazil
Hospital São Camilo
São Paulo, São Paulo, Brazil