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).
This is a prospective, multicenter clinical investigation 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). The target population for this clinical study consists exclusively of patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who require emergency percutaneous coronary intervention (PCI) treatment. The clinical outcome data collected will be based on the site's standards of care for acute STEMI. Examinations include but are not limited to physical assessments, cardiac markers, ECG, laboratory results, x-rays, angiograms, cMRI, and echocardiography. Endpoint data will be collected at multiple follow-up intervals: during CSBP therapy, immediately following device explantation, at 5 days and 30 days post-procedure, and subsequently at 4-month, 6-month, and 12-month follow-up visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The 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)
Time frame: 24 hours, 30 days post-procedure
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
Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure
Kefei Do, M.D.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.