Myocardial infarction
Conditions
Interventions
Subjects will be randomized (1:1) to the experimental group or the control
group at the planned Month 1 visit to the hospital. Assigned treatment will
start at the timepoint of randomization.
Sponsors
Sorin Biomedica CRM SRL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for enrolment: Clinical • Subject is >= 18 years old • Subject has been hospitalised for troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and this PCI occurred within the last 7 days • Subject is eligible for per-protocol antiplatelet treatments • Subject understands and agrees with the trial requirements and procedures, and provides written informed consent before any trial-specific tests or procedures are performed • Subject is willing to comply with all protocol requirements including antiplatelet treatment strategies and follow-up visits Procedural/angiographic (related to the treatment of the (N)STEMI • Successful revascularization: - Successful delivery and deployment of the Firehawk stent(s), with final residual stenosis of <30% (visually) for all target lesions - No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding). • All the treated lesions: - In native coronary arteries only, - In vessels with visual reference diameter >=2.25 mm and
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible: • Subjects with prior STEMI or prior PCI within 12 months before index admission • Prior Coronary Artery Bypass Graft (CABG) Surgery • Cardiogenic shock • Secondary PCI • Fibrinolysis • Prior stent thrombosis • Planned PCI, CABG, or surgery within 12 months after the enrolment • Need for Oral Anti-Coagulation medications (or NOAC) • Ischemic stroke or intracerebral hemorrhage (spontaneous or traumatic) within 12 months prior to index procedure • eGFR <30 mL/min/1.73 m2 or dialysis • Active bleeding at time of inclusion or high risk for major bleeding • History of bleeding diathesis or coagulopathy or subject refuse blood transfusions • Stage B or C liver cirrhosis or active cancer within 12 months prior to index procedure (or currently receiving chemotherapy or planned to receive chemotherapy) • Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure • Moderate or severe thrombocytopenia (<100,000/L) • Expected non-adherence to study protocol (such as current problems with substance abuse, severe impairment of cognitive skills, *) • Estimated life expectancy = 2mm (visual reference visual diameter) or bifurcation treated with 2 stents - Left main coronary artery lesion - Residual untreated dissection >= C - Implantation of a non-study stent • Extent and severity of disease is such that patient is deemed to receive preferentially CABG within 1 year (based on current ESC guidelines)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| BARC type 2, 3 or 5 bleeding events at 11 months post randomization (powered) Other secondary endpoints (exploratory) are clinical endpoints at 1 month, 6 months and 12 months: • All-cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, or stroke • BARC 3 and 5 bleeding events • All-cause death or non-fatal myocardial infarction • Patient-oriented composite of major adverse cardiac and cerebral events (MACCE) including all-cause death, myocardial infarction, definite/probable stent thrombosis, any stroke, any Ischemia driven repeat revascularization,, or BARC bleeding events (type 2, 3, or 5) • Device oriented composite endpoint of Target Lesion Failure (cardiac death, target vessel related myocardial infarction, target lesion Ischemia Driven-revascularization) • MACE (cardiovascular death, myocardial infarction, Ischemia Driven-revascularization) • Definite or probable stent thrombosis • BARC 3 events • BARC 5 events • BARC 2 events • Cardiovascular death • Cardiac death • Non cardiac death • Myocardial infarction • Cardiac death or non-fatal myocardial infarction • Cardiac death, myocardial infarction, or definite/probable stent thrombosis • Cardiovascular death, myocardial infarction, definite/probable stent thrombosis, or ischemic stroke • Ischemic stroke • Haemorrhagic stroke • Ischemia-driven target lesion revascularization • Ischemia-driven target vessel revascularization • Cardiovascular death, myocardial infarction, or ischemic stroke and each of the components of the primary and main secondary endpoints | — |
Countries
Netherlands
Outcome results
None listed