Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

Scitech Produtos Medicos SA299 enrolled

Overview

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Coronary Artery Disease

Interventions

AngioplastyDEVICE

Inspiron Drug Eluting stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent. Exclusion Criteria: * Saphenous vein grafts or Mammary lesions; * Individuals who have been treated within the last 6 months with another stent; * Acute myocardial infarction with ST segment elevation; * Chronic Total Occlusion

Locations (2)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto do Coração - INCOR

São Paulo, Brazil

Outcomes

Primary Outcomes

MACE (major cardiac events)

Major cardiac events (death, myocardial infarction, target vessel revascularization)

Time frame: 12 months

Secondary Outcomes

Acute success

Acute success measured by Angiography after stent implantation

Time frame: up to 24 hours

Stent Thrombosis

Stent Thrombosis rate

Time frame: 24 months

MACE

Major cardiac events (death, myocardial infarction, target vessel revascularization)

Time frame: 24 months

Data from ClinicalTrials.gov

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