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Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent — Inspiron RL II  

Coronary Artery Disease Clinical Trial

Official title:
Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03263260
Study type Observational [Patient Registry]
Source Scitech Produtos Medicos Ltda
Contact
Status Active, not recruiting
Phase
Start date June 2, 2017
Completion date December 30, 2023
View Details
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