Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

NCT ID: NCT03263260

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-02

Study Completion Date

2024-01-21

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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implanted patients

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

implant

Intervention Type DEVICE

coronary stent implantation

Interventions

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implant

coronary stent implantation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Inspiron RL II

Identifier Type: -

Identifier Source: org_study_id

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