OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

Scitech Produtos Medicos SA36 enrolled

Overview

Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Sirolimus Eluting Stent InspironDEVICE

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

Bare Metal StentDEVICE

Angioplasty with Bare Metal Stent Cronus implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * one or two de novo lesions (\> 50% visual estimation) * lesion diameter between 2.5 and 3.5 mm * lesion length up to 33 mm. Exclusion Criteria: * MI within the last 72 hours * restenotic lesion.

Locations (1)

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Safety

Percentage of strut coverage by OCT

Time frame: 3 months

Data from ClinicalTrials.gov

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