Bifurcation LesioninsProvisionalNCT03780192
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
An observational study of Bifurcation Lesion and Coronary Artery Disease, run by Scitech Produtos Medicos SA at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bifurcation Lesion, Coronary Artery Disease
- What is being tested?
- Inspiron Sirolimus Eluting Stent
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2019to 15 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with bifurcation coronary artery disease with indication for drug eluting implantation.
Who may be able to join
- 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).
Who cannot join
- Acute Myocardial Infarction (STMI);
- Chronic occlusion;
- Cardiogenic shock;
- Ejection fraction ≤ 20%;
- Thrombocytopenia (≤ 50 mil);
- DAPT contraindication;
- Life expectancy of less than 12 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul
Marco Wainstein, MD, marco.wainstein@hmv.org.br
Marco W Wainstein, MD
About this study
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
- Bifurcation Lesion, Coronary Artery Disease
- Being tested
- Inspiron Sirolimus Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiron Sirolimus Eluting StentDevice
Bifurcation treatment using provisional stent technique
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Bifurcation lesion treatment using provisional stent technique Receives: Device: Inspiron Sirolimus Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Stenosis
% of stenosis on side branch after stent placement on main vessel
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start28 Feb 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bifurcation LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Marco Vugman Wainstein, Scitech Produtos Medicos SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780192
- Sponsor's protocol ID
- SC-INS-001-2019
- Acronym
- insProvisional
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
- ClinicalTrials.gov ID
- NCT03780192
- Acronym / sponsor ID
- insProvisional / SC-INS-001-2019
- Conditions
- Bifurcation Lesion, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Inspiron Sirolimus Eluting StentBifurcation lesion treatment using provisional stent technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with bifurcation coronary artery disease with indication for drug eluting implantation.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- Acute Myocardial Infarction (STMI);
- Chronic occlusion;
- Cardiogenic shock;
- Ejection fraction ≤ 20%;
- Thrombocytopenia (≤ 50 mil);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiron Sirolimus Eluting StentBifurcation treatment using provisional stent technique | Device | Treatment |
Primary outcome
Percentage of Stenosis
Time frame: day 0
% of stenosis on side branch after stent placement on main vessel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bifurcation Lesion and Coronary Artery Disease, run by Scitech Produtos Medicos SA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Wainstein, MD (+555133143537, marco.wainstein@hmv.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Stenosis (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.