STEMI - ST Elevation Myocardial InfarctionNCT03609346
Asian Registry of the BioFreedom Stent for STEMI Patients
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Biosensors Europe SA at 5 sites in 5 countries.
Trial summary
The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- PCI
- Type of treatment
- Medical device
- How many people
- 914 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 22 Nov 2018to 5 Aug 2022
- How long will I take part?
- 12 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The registry is open to all patients presenting with STEMI and treated with one or more BioFreedom BA9 (SS) DCS.
Who may be able to join
- STEMI patients treated with one or several BioFreedom stent(s) within 12h of symptom onset
- Patients who agree to comply with the follow up requirements.
- Patients with a life expectancy of > 1 year at time of consent.
- Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.
Who cannot join
- Patients in cardiogenic shock
- Any out of hospital cardiac arrest
- Glasgow score < 15
- Patients unable or unwilling to give documented informed consent
- Patients with any PCI 6 months prior to the baseline procedure
- Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
- Patient has received an additional stent different from a BioFreedomBA9 (SS) DCS stent during the index procedure.
- Pregnant or breastfeeding women
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)
The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.
Read the detailed description
The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use.
The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization.
The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock.
Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system.
All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced.
Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant.
- Being tested
- PCI
- Keywords
- STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
Also called Revascularization
The placement of 1 or more stents in the diseased coronary artery lesion(s).
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Arm: STEMI Intervention: PCI with 1 or more BioFreedom stents in patients presenting with a STEMI. Medication according to hospital practice. Receives: Device: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
TLF (Target Lesion Failure) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions).
Measured: 12 months
Secondary outcomes (10)
1. All-cause mortality
- All-cause mortality
Measured: 12 months
2. Cardiovascular death
- Cardiovascular death (cardiovascular and undetermined)
Measured: 12 months
3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis
- The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis at one year
Measured: 12 months
4. Stroke disabling and non-disabling ARC definition
- Stroke disabling and non-disabling ARC definition
Measured: 12 months
5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions
- Myocardial infarction (according to the Third Universal Definition)
- Q wave, non-Q wave and all myocardial infarctions
Measured: 12 months
6. ARC2 ST
- ARC2 ST
Measured: 12 months
7. Clinically driven TLR at any follow-up time point
- Clinically driven TLR at any follow-up time point
Measured: 12 months
8. Clinically driven target vessel revascularization
- Clinically driven target vessel revascularization
Measured: 12 months
9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month
- Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month
Measured: 12 months
10. Bleeding per BARC criteria a. BARC 3 to 5
- Bleeding per BARC criteria
- BARC 3 to 5
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start22 Nov 2018
- Primary completion30 Jan 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 914 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosensors Interventional Technologies Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609346
- Sponsor's protocol ID
- 18-APAC-01
- Status last verified
- Feb 2024
- First submitted
- 25 Jul 2018
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ong PJL, Chui SF, Tam FC, Nguyen QT, Tsai CT, Kang WC, Nuruddin AA, Singh R, Chotinaiwattarakul C, Lee M. Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients. Catheter Cardiovasc Interv. 2024 Dec;104(7):1406-1413. doi: 10.1002/ccd.31263. Epub 2024 Oct 21.
PubMed 39434554
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT03609346
- Acronym / sponsor ID
- 18-APAC-01
- Keywords
- STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Collaborators
- Biosensors Interventional Technologies Pte Ltd
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 1 Aug 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.
The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.
Detailed description
The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use.
The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization.
The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock.
Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system.
All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced.
Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Device: PCIArm: STEMI Intervention: PCI with 1 or more BioFreedom stents in patients presenting with a STEMI. Medication according to hospital practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The registry is open to all patients presenting with STEMI and treated with one or more BioFreedom BA9 (SS) DCS.
Key inclusion criteria (4 listed)
- STEMI patients treated with one or several BioFreedom stent(s) within 12h of symptom onset
- Patients who agree to comply with the follow up requirements.
- Patients with a life expectancy of > 1 year at time of consent.
- Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.
Key exclusion criteria (8 listed)
- Patients in cardiogenic shock
- Any out of hospital cardiac arrest
- Glasgow score < 15
- Patients unable or unwilling to give documented informed consent
- Patients with any PCI 6 months prior to the baseline procedure
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 |
|---|---|---|
| PCIAlso: RevascularizationThe placement of 1 or more stents in the diseased coronary artery lesion(s). | Device | STEMI |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
TLF (Target Lesion Failure) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions).
10 secondary outcomes
1. All-cause mortality
Time frame: 12 months
2. Cardiovascular death
Time frame: 12 months
3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis
Time frame: 12 months
4. Stroke disabling and non-disabling ARC definition
Time frame: 12 months
5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions
Time frame: 12 months
6. ARC2 ST
Time frame: 12 months
7. Clinically driven TLR at any follow-up time point
Time frame: 12 months
8. Clinically driven target vessel revascularization
Time frame: 12 months
9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month
Time frame: 12 months
10. Bleeding per BARC criteria a. BARC 3 to 5
Time frame: 12 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 29 Feb 2024.
- Derived from this study: PubMed 39434554Ong PJL, Chui SF, Tam FC, Nguyen QT, Tsai CT, Kang WC, Nuruddin AA, Singh R, Chotinaiwattarakul C, Lee M. Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients. Catheter Cardiovasc Interv. 2024 Dec;104(7):1406-1413. doi: 10.1002/ccd.31263. Epub 2024 Oct 21.
- 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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Biosensors Europe SA at 5 sites in 5 countries.
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 4 inclusion and 8 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hong Kong, Singapore, South Korea, Taiwan, Thailand. 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?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609346, which also lists 1 linked publication.
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 29 Feb 2024.