Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03471234
- Lead Sponsor
- Scitech Produtos Medicos Ltda
- Brief Summary
Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACE (major cardiac events) 12 months Major cardiac events (death, myocardial infarction, target vessel revascularization)
- Secondary Outcome Measures
Name Time Method Acute success up to 24 hours Acute success measured by Angiography after stent implantation
Stent Thrombosis 24 months Stent Thrombosis rate
MACE 24 months Major cardiac events (death, myocardial infarction, target vessel revascularization)
Trial Locations
- Locations (2)
Instituto do Coração - INCOR
🇧🇷São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, Brazil