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

Scitech Produtos Medicos

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: implant

Study type: Observational

Funder types: Industry

Identifiers

NCT03263260

Inspiron RL II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,504 participants in 1 patient group

implanted patients

Description:

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

Treatment:

Device: implant