Status unknownNCT03780192insProvisionalUpdated Mar 17, 2020

INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

An observational study in Bifurcation Lesion and Coronary Artery Disease, sponsored by Scitech Produtos Medicos Ltda. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Scitech Produtos Medicos Ltda · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

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Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 80
Ages: 18 Years and older
Sex: All

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.

Planned enrollment: 22nd of 28; 80 · median 740
Started: 2019; with 6 others
Observational: 29 of 152; 6 open now
Registered: 97th 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 22nd largest by planned enrollment of the 28 observational ones that give a count, is one of 7 that started in 2019, is one of 29 observational ones, and was the 97th 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:

RecruitingNCT07491107
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
Scitech Produtos Medicos SA · Sites in Brazil
Ages 18+
RecruitingNCT07865377
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
InCor Heart Institute · Sites in Brazil
Ages 45–70 · Women only
RecruitingNCT07777341
Study Evaluating the Effects of Red Grape Juice Consumption on Metabolism in Men With Coronary Artery Disease
University of Sao Paulo General Hospital · Sites in Brazil
Ages 46–69 · Men only
RecruitingNCT06579807
Cardiac Rehabilitation and Coronary Artery Disease
Instituto Nacional de Cardiologia de Laranjeiras · Sites in Brazil
Ages 40–70 · Healthy volunteers
RecruitingNCT06900270
Comparative of Plasma Proteomics & Metabolomics in Coronary Artery Disease: Obstructive,Non-Obstructive, & No Lesions
University of Sao Paulo General Hospital · Sites in Brazil
Ages 50–80 · Healthy volunteers

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 →

This tab as a report to print or save as PDF → With an account.

Who runs the 152 studies in Coronary Artery Disease with a site in Brazil

60 of 152 have an industry lead sponsor. The 10 most frequent:

University of Sao Paulo General Hospital14 · 4 open

University of Sao Paulo11

Scitech Produtos Medicos Ltda9 · industry

Cordis Corporation6 · industry

InCor Heart Institute6 · 2 open

Abbott Medical Devices4 · industry

AstraZeneca4 · industry

Elixir Medical Corporation4 · industry

Instituto de Cardiologia do Rio Grande do Sul4 · 1 open

Ministry of Health, Brazil4

Scitech Produtos Medicos Ltda in Coronary Artery Disease

Scitech Produtos Medicos Ltda is the lead sponsor of 13 studies on the registry; none are open to participants now.

Scitech Produtos Medicos Ltda has 9 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.

Its Coronary Artery Disease studies →

Coming up

3 of the studies in Coronary Artery Disease with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:

Study	Primary completion
NCT06579807Instituto Nacional de Cardiologia de LaranjeirasCardiac Rehabilitation and Coronary Artery Disease	2026-12-31
NCT07699679Federal University of São PauloPhotobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting.	2027-08
NCT07734831University of the State of Santa CatarinaTELEREHAB-BR: Cardiovascular Rehabilitation Models Trial	2027-08

Add all 3 to your calendar (.ics) → With an account.

What changed since 2026-09-25

Among the 152 studies in Coronary Artery Disease with a site in Brazil, from their registry updates:

Newly registered 1

NCT078653772026-10-08Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation

Started recruiting 1

NCT074911072026-10-02Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

Primary completion moved 2

NCT042366092026-10-262023-10-30 → 2023-11-30Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
NCT074911072026-10-022030-10-01 → 2030-10-30Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

This tab as a report to print or save as PDF → With an account.

Watch this landscape Download CSV Narrow 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.

Study summary

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

Conditions studied

Bifurcation Lesion
Coronary Artery Disease

Browse trials for

Coronary Artery Disease 4,862

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

All patients with bifurcation coronary artery disease with indication for drug eluting implantation.

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

Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

Exclusion criteria

Exclusion Criteria:

Acute Myocardial Infarction (STMI);
Chronic occlusion;
Cardiogenic shock;
≤ 20%;
Thrombocytopenia (≤ 50 mil);
DAPT ;
of less than 12 months.

Terms in these criteria, in plain language(3)

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.

LVEF (left ventricular ejection fraction): The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy: The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 80 participants (estimated)
Patient registry: No

Groups and cohorts

Treatment
Bifurcation lesion treatment using provisional stent technique
Device: Inspiron Sirolimus Eluting Stent

Interventions

DeviceInspiron Sirolimus Eluting Stent
Bifurcation treatment using provisional stent technique

What researchers measure

Primary outcomes

Percentage of Stenosis
% of stenosis on side branch after stent placement on main vessel
Time frame: day 0

Study locations

1 of 1 sites recruiting

Hospital Moinhos de Vento
Porto Alegre, RS, Brazil
Recruiting
- Marco Wainstein, MD · Contact · marco.wainstein@hmv.org.br
- Marco W Wainstein, MD · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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

Started Feb 2019 (actual). Primary completion is estimated for Feb 2021, 23 months after the start.

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 planned 23 months is below 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: Dec 17, 2018
First posted: Dec 19, 2018
StartActual: Feb 28, 2019
Primary completionEst.: Feb 15, 2021
CompletionEst.: Feb 15, 2022
Last update: Mar 17, 2020

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 Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03780192
Lead sponsor: Scitech Produtos Medicos Ltda
Responsible party: Marco Vugman Wainstein (Principal Investigator Hospital Moinhos de Vento, Scitech Produtos Medicos Ltda) — Principal investigator
First posted: Dec 19, 2018
Start date: Feb 28, 2019
Primary completion: Feb 15, 2021 (estimated)
Completion: Feb 15, 2022 (estimated)
Last update: Mar 17, 2020

Study contacts

Marco Wainstein, MD

Contact

marco.wainstein@hmv.org.br

+555133143537

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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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.

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