ClinicalTrials.gg
CompletedNCT03263260Inspiron RL IIUpdated Sep 4, 2024

Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

An observational study in Coronary Artery Disease, sponsored by Scitech Produtos Medicos Ltda. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.

Sponsored by Scitech Produtos Medicos Ltda · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,504
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
8th of 28
2,504 · median 740
Started
2017
with 10 others
Observational
29 of 152
6 open now
Registered
88th 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 8th largest by enrollment of the 28 observational ones that give a count, is one of 11 that started in 2017, is one of 29 observational ones, and was the 88th 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.

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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

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.

Read the detailed description

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.

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • stent, DES, 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 older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries

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

  • alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

Exclusion criteria

Exclusion Criteria:

  • Safein Vein or Left Internal Mammary artery Grafts
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,504 participants (actual)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • implanted patients

    Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent

    Device: implant

Interventions

  • Deviceimplant

    coronary stent implantation

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiac Events Rate

    Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis

    Time frame: 12 months

Secondary outcomes

  1. Target Vessel and Lesion Revascularization Rates

    Target Vessel and Lesion Revascularization

    Time frame: 24 months

  2. Stent Thrombosis Rate

    Stent Thrombosis

    Time frame: 24 months

07

Study locations

1 site
  • União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS
    Porto Alegre, Rio Grande Do Sul 90.619-900, 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 Jun 2017 to primary completion in Dec 2022, 66 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 66 months is above 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
Aug 24, 2017
First posted
Aug 28, 2017
StartActual
Jun 2, 2017
Primary completionActual
Dec 15, 2022
CompletionActual
Jan 21, 2024
Last update
Sep 4, 2024
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 Sep 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03263260
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Aug 28, 2017
Start date
Jun 2, 2017
Primary completion
Dec 15, 2022
Completion
Jan 21, 2024
Last update
Sep 4, 2024

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 Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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