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

May 17, 2023 updated by: Scitech Produtos Medicos Ltda

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Instituto do Coração - InCor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (major cardiac events)
Time Frame: 12 months
Major cardiac events (death, myocardial infarction, target vessel revascularization)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute success
Time Frame: up to 24 hours
Acute success measured by Angiography after stent implantation
up to 24 hours
Stent Thrombosis
Time Frame: 24 months
Stent Thrombosis rate
24 months
MACE
Time Frame: 24 months
Major cardiac events (death, myocardial infarction, target vessel revascularization)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scitech Produtos Medicos Ltda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

August 2, 2022

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-CO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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