CClinicalTrials.gg
CompletedNCT03471234LATITUDEUpdated May 18, 2023

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

An observational study in Coronary Artery Disease, sponsored by Scitech Produtos Medicos Ltda. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-18.

Sponsored by Scitech Produtos Medicos Ltda · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
299
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • coronary disease
  • drug eluting stent
  • Inspiron
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
299 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DeviceAngioplasty

    Inspiron Drug Eluting stent implantation

05

What researchers measure

Primary outcomes

  1. MACE (major cardiac events)

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

    Time frame: 12 months

Secondary outcomes

  1. Acute success

    Acute success measured by Angiography after stent implantation

    Time frame: up to 24 hours

  2. Stent Thrombosis

    Stent Thrombosis rate

    Time frame: 24 months

  3. MACE

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

    Time frame: 24 months

06

Study locations

2 sites
  • Instituto Dante Pazzanese de Cardiologia
    São Paulo, Brazil
  • Instituto do Coração - INCOR
    São Paulo, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03471234
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Sep 3, 2018
Primary completion
Oct 30, 2020
Completion
Aug 2, 2022
Last update
May 18, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion