The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.
This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 randomized patients. Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
stent implantation
stent implantation
Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil
Encore - Cardiologia e Radiologia Intervencionista
Goiânia, Goiás, Brazil
Hospital Cardiologico Costantini
Curitiba, Paraná, Brazil
Lumen Loss
For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months.
Time frame: 9 months after the procedure
Adverse Cardiac Events
The clinical follow-up should be performed during the index procedure at 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald for unstable angina) and major adverse cardiac avents and any interventional treatment (e.g: repeated targetlesion revascularization or recurrent ischemia)
Time frame: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.
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Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Bandeirantes de São Paulo
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
Instituto de Assistência Médica ao Servidor Publico Estadual
São Paulo, São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, Brazil