Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

Korábbi kezelés

• Subjects with prior STEMI or prior PCI within 12 months before index admission
• Prior Coronary Artery Bypass Graft (CABG) Surgery
• Prior stent thrombosis
• Planned PCI, CABG, or surgery within 12 months
• Need for Oral Anti-Coagulation therapy
• True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents

Más betegség

• Ischemic stroke or ICH within 12 months
• 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
• Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds
• In-stent restenosis or thrombosis

Laborértékek

• eGFR <30 mL/min/1.73 m2 or dialysis
• Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure

Egyéb

• Cardiogenic shock
• Secondary PCI
• Fibrinolysis
• Moderate or severe thrombocytopenia
• Expected non-adherence to protocol or estimated life expectancy ≤12 months
• Participation in another interventional clinical trial
• Woman who is pregnant, nursing or with known intention to procreate
• Chronic total occlusion
• Severe calcification
• Left main coronary artery lesion
• Residual untreated dissection ≥ C
• Implantation of a non-study stent
• Subject is deemed to receive preferentially CABG within 1 year

• Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days
• Subject is eligible for per-protocol antiplatelet treatments
• Written informed consent
• Successful revascularization
• All treated lesions:
  • In native coronary arteries only
  • In vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm
  • Implanted with the study device
  • Maximum 3 lesions treated (*)
  • Maximum total stent length ≤ 80 mm
• Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure.