Clinical trial NCT03609346: Asian Registry of the BioFreedom Stent for STEMI Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: STEMI
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: Biosensors Interventional Technologies Pte Ltd
First posted: 2018-08-01
Enrollment: 914
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry is open to all patients presenting with STEMI and treated with one or more BioFreedom BA9 (SS) DCS.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

1. STEMI patients treated with one or several BioFreedom stent(s) within 12h of symptom onset
2. Patients who agree to comply with the follow up requirements.
3. Patients with a life expectancy of \> 1 year at time of consent.
4. Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.

Exclusion Criteria:

1. Patients in cardiogenic shock
2. Any out of hospital cardiac arrest
3. Glasgow score \< 15
4. Patients unable or unwilling to give documented informed consent
5. Patients with any PCI 6 months prior to the baseline procedure
6. Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
7. Patient has received an additional stent different from a BioFreedomBA9 (SS) DCS stent during the index procedure.
8. Pregnant or breastfeeding women

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: 1. All-cause mortality
timeFrame: 12 months
measure: 2. Cardiovascular death
timeFrame: 12 months
measure: 3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis
timeFrame: 12 months
measure: 4. Stroke disabling and non-disabling ARC definition
timeFrame: 12 months
measure: 5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions
timeFrame: 12 months
measure: 6. ARC2 ST
timeFrame: 12 months
measure: 7. Clinically driven TLR at any follow-up time point
timeFrame: 12 months
measure: 8. Clinically driven target vessel revascularization
timeFrame: 12 months
measure: 9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month
timeFrame: 12 months
measure: 10. Bleeding per BARC criteria a. BARC 3 to 5
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Bangkok
country: Thailand
facility: Her Majesty Cardiac Centre
Study officials:
References: