Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: implant

• 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.

Study Timeline

• Study Start: 2017-06-02
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Primary Completion: 2022-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
implanted patients	implant	Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent

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
Stent Thrombosis Rate	24 months	Stent Thrombosis
Target Vessel and Lesion Revascularization Rates	24 months	Target Vessel and Lesion Revascularization

Trial Locations

Locations (1)

União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil