Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Scitech Produtos Medicos Ltda
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiac Events Rate
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years
Exclusion Criteria
- •Safein Vein or Left Internal Mammary artery Grafts
Outcomes
Primary Outcomes
Major Adverse Cardiac Events Rate
Time Frame: 12 months
Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
Secondary Outcomes
- Target Vessel and Lesion Revascularization Rates(24 months)
- Stent Thrombosis Rate(24 months)