This is a prospective, multicenter clinical investigation aiming to evaluate the safety and efficacy of the coronary sinus balloon pump in its first application in patients with acute ST-segment elevation myocardial infarction (STEMI).
Subjects aged ≥18 and ≤80 years with clinically confirmed ST-segment elevation myocardial infarction (STEMI).
Left Ventricular Dysfunction: Left ventricular ejection fraction (LVEF) ≤50% assessed by pre-PCI echocardiography or left ventriculography.
Ischemic Symptoms: Presence of myocardial infarction symptoms consistent with ischemic timing (e.g., persistent chest pain, with or without dyspnea, nausea/vomiting, diaphoresis, syncope), with symptom onset between 6 and 24 hours prior to enrollment.
Acute anterior wall myocardial infarction confirmed by 12-lead ECG, demonstrating ST-segment elevation ≥1 mm (0.1 mV) in ≥2 contiguous precordial leads.
Presence of implants or foreign bodies within the coronary sinus.
Target lesion involving the left main coronary artery or ≥50% stenosis in the left main coronary artery.
Known hypersensitivity to medications or devices required during PCI or the investigational device (including but not limited to: rapamycin, polyurethane in dual antiplatelet therapy, PET, or stainless steel).
Pericardial effusion (moderate or larger volume), cardiac tamponade, hemodynamically significant left/right shunts, or severe valvular heart disease.
Single group
the coronary sinus balloon pump
DeviceThe coronary sinus balloon pump comprises a coronary sinus balloon pump catheter system and a coronary sinus balloon pump therapeutic device. This product is indicated for the treatment of ST-segment elevation myocardial infarction (STEMI) with or without coronary microvascular dysfunction (CMD), by intermittently occluding coronary sinus blood flow during percutaneous coronary intervention (PCI) procedures to reduce myocardial infarction size.
Device-related procedural complication rate
Device-related procedural complication rate \[24 hours, 30 days post-procedure\]: Complications include: * Access site complications: BARC type 3-5 bleeding; infection requiring oral/intravenous antibiotics; or access site complications requiring surgical intervention * Coronary sinus dissection or perforation requiring interventional/surgical treatment * Pericardial effusion or cardiac tamponade requiring interventional/surgical treatment * Thrombosis or embolism * Stroke (Note: CEC adjudication required to determine device-relatedness)
MACCE (Major Adverse Cardiac and Cerebrovascular Events)
MACCE (Major Adverse Cardiac and Cerebrovascular Events) \[5 days, 30 days, 4 months, 6 months, 12 months post-procedure\]: * Cardiac death * Hospitalization for heart failure * New-onset heart failure or worsening of pre-existing heart failure * Ventricular tachycardia/fibrillation requiring cardioversion/defibrillation * Myocardial infarction (MI) * Target vessel revascularization (TVR) * Stent thrombosis * Major bleeding (BARC type 3-5) * Stroke
All-cause mortality rate (cardiac, vascular, non-vascular)
Heart failure hospitalization rate
New-onset/worsening heart failure rate
MI incidence
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