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OpenTrials
Completed

NCT Number: NCT03263260

Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Dysequilibrium syndrome Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Porto Alegre, Rio Grande do Sul, 90.619-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implant

Device

coronary stent implantation

Primary outcomes

  1. Major Adverse Cardiac Events Rate

    Time frame: 12 months

    Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis

Secondary outcomes

  1. Target Vessel and Lesion Revascularization Rates

    Time frame: 24 months

    Target Vessel and Lesion Revascularization

  2. Stent Thrombosis Rate

    Time frame: 24 months

    Stent Thrombosis

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study 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)

Acronym: Inspiron RL II

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Aug 28, 2017
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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