Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03263260
- Lead Sponsor
- Scitech Produtos Medicos Ltda
- Brief Summary
Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.
- Detailed Description
Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.
Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.
Patients will be followed at 30 days, 1 and 2 years after procedure.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years
- Safein Vein or Left Internal Mammary artery Grafts
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events Rate 12 months Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
- Secondary Outcome Measures
Name Time Method Target Vessel and Lesion Revascularization Rates 24 months Target Vessel and Lesion Revascularization
Stent Thrombosis Rate 24 months Stent Thrombosis
Trial Locations
- Locations (1)
União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil