Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

Coronary Artery Disease Clinical Trial

— Inspiron RL II  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03263260
• Other study ID #: Inspiron RL II
• Status: Active, not recruiting
• Start date: June 2, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• implant
coronary stent implantation

Locations

Country	Name	City	State
Brazil	União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events Rate	Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis	12 months
Secondary	Target Vessel and Lesion Revascularization Rates	Target Vessel and Lesion Revascularization	24 months
Secondary	Stent Thrombosis Rate	Stent Thrombosis	24 months