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Completed

NCT Number: NCT03471234

Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil

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About this study

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion criteria

  • Saphenous vein grafts or Mammary lesions;
  • Individuals who have been treated within the last 6 months with another stent;
  • Acute myocardial infarction with ST segment elevation;
  • Chronic Total Occlusion

Treatment and study plan

Angioplasty

Device

Inspiron Drug Eluting stent implantation

Primary outcomes

  1. MACE (major cardiac events)

    Time frame: 12 months

    Major cardiac events (death, myocardial infarction, target vessel revascularization)

Secondary outcomes

  1. Acute success

    Time frame: up to 24 hours

    Acute success measured by Angiography after stent implantation

  2. Stent Thrombosis

    Time frame: 24 months

    Stent Thrombosis rate

  3. MACE

    Time frame: 24 months

    Major cardiac events (death, myocardial infarction, target vessel revascularization)

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study title

LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.

Acronym: LATITUDE

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Mar 20, 2018
Registry last updated
May 18, 2023

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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