Status:
COMPLETED
Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Lead Sponsor:
Scitech Produtos Medicos Ltda
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT03471234
Start Date
September 3 2018
End Date
August 2 2022
Last Update
May 18 2023
Active Locations (2)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
2
Instituto do Coração - INCOR
São Paulo, Brazil