Coronary Artery DiseaseInspiron RL IINCT03263260
Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent
An observational study of Coronary Artery Disease, run by Scitech Produtos Medicos SA at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- implant
- Type of treatment
- Medical device
- How many people
- 2,504 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2017to 21 Jan 2024
- How long will I take part?
- 24 Months
- 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: Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries
Who may be able to join
- alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years
Who cannot join
- Safein Vein or Left Internal Mammary artery Grafts
Trial locations and contacts
1 site in 1 country.
Brazil1 site
União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS
Porto Alegre, Rio Grande do Sul, 90.619-900
About this study
Official title: Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
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.
- Conditions
- Coronary Artery Disease
- Being tested
- implant
- Keywords
- stent, DES, Inspiron
- Medical subject headings
- Coronary Artery Disease, Dysequilibrium syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantDevice
coronary stent implantation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events Rate
Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
Measured: 12 months
Secondary outcomes (2)
Target Vessel and Lesion Revascularization Rates
Target Vessel and Lesion Revascularization
Measured: 24 months
Stent Thrombosis Rate
Stent Thrombosis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start2 Jun 2017
- Primary completion15 Dec 2022
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 2,504 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263260
- Sponsor's protocol ID
- Inspiron RL II
- Acronym
- Inspiron RL II
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2017
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
- ClinicalTrials.gov ID
- NCT03263260
- Acronym / sponsor ID
- Inspiron RL II / Inspiron RL II
- Conditions
- Coronary Artery Disease
- Keywords
- stent, DES, Inspiron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,504 participants (actual)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 28 Aug 2017 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| implanted patients | – | Device: implantPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries
Key inclusion criteria (1 listed)
- alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years
Key exclusion criteria (1 listed)
- Safein Vein or Left Internal Mammary artery Grafts
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 |
|---|---|---|
| implantcoronary stent implantation | Device | implanted patients |
Primary outcome
Major Adverse Cardiac Events Rate
Time frame: 12 months
Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
2 secondary outcomes
Target Vessel and Lesion Revascularization Rates
Time frame: 24 months
Stent Thrombosis Rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 1 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: finished, as of the sponsor's last update on 4 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events Rate (time frame: 12 months). 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 4 Sep 2024.