ClinicalTrials.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

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

Where this study stands

Counted across the records on this site · 2026-11-15

Among 152 studies in Coronary Artery Disease with a site in Brazil — 22 open to participants now, 30 under way, 4 of them phase 3. Coronary Artery Disease · Brazil.

Enrollment
18th of 28
299 · median 740
Started
2018
with 6 others
Observational
29 of 152
6 open now
Registered
92nd of 152
by date
Lead sponsor
9 of 152
Scitech Produtos Medicos Ltda

Among the 152 studies in Coronary Artery Disease with a site in Brazil, this one is the 18th largest by enrollment of the 28 observational ones that give a count, is one of 7 that started in 2018, is one of 29 observational ones, and was the 92nd registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

22 of the 152 studies in Coronary Artery Disease with a site in Brazil are open now. Recruiting first, the newest first:

17 more — sign in →

All 22 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 152 studies in Coronary Artery Disease with a site in Brazil, or all of them as a file.
02

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.

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • coronary disease
  • drug eluting stent
  • Inspiron
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All individuals aged over 18 years who signed the 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

2 sites
  • Instituto Dante Pazzanese de Cardiologia
    São Paulo, Brazil
  • Instituto do Coração - INCOR
    São Paulo, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Oct 2020, 25 months.

Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 25 months is close to that.

Counting every sponsor, half of 761 studies reached it within 41 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 20, 2018
StartActual
Sep 3, 2018
Primary completionActual
Oct 30, 2020
CompletionActual
Aug 2, 2022
Last update
May 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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