The Coronary Sinus Balloon Pump in STEMI (NCT07354035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Coronary Sinus Balloon Pump in STEMI
177 participantsStarted 2026-02-12
Plain-language summary
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of the coronary sinus balloon pump (manufactured by Shanghai MicroPort Rotapace Medical Technology Co., Ltd.) as an adjunctive therapy during percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). As a pivotal study, it aims to support the product registration application to the National Medical Products Administration (NMPA).
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Subjects aged ā„18 and ā¤80 years, clinically diagnosed with ST-segment elevation myocardial infarction (STEMI).
ā. Left ventricular ejection fraction (LVEF) ā¤50% and ā„35% as assessed by echocardiography or left ventriculography prior to PCI.
ā. Symptoms of myocardial infarction (e.g., persistent chest pain, with or without shortness of breath, nausea/vomiting, profuse sweating, dyspnea, syncope) consistent with the timing of myocardial ischemia, with symptom onset within 24 hours.
ā. Electrocardiographic evidence of acute anterior wall myocardial infarction, defined as ST-segment elevation ā„1 mm (0.1 mV) in at least two contiguous precordial leads on a 12-lead ECG. For leads V2 or V3, the following gender- and age-specific cutoffs apply:
ā. Subject is eligible for primary percutaneous coronary intervention (primary PCI).
ā. Subject is able to understand the purpose of the study, voluntarily agrees to participate by signing the informed consent form acknowledging the risks and benefits described therein, and is willing and able to comply with the required clinical follow-up procedures.
ā. The target lesion is located in the proximal or mid segment of the left anterior descending artery (LAD).
ā. TIMI flow grade of the target vessel is 0, 1, or 2 prior to PCI treatment.
Exclusion criteria
ā. Presence of an implant or foreign body within the coronary sinus.
ā
What they're measuring
1
Myocardial infarct size
Timeframe: 5 days after the procedure
2
Incidence of Major Adverse Events (MAE) (Experimental Group)
. The target lesion involves the left main coronary artery, or there is a ā„50% stenosis in the left main coronary artery.
ā. Known allergy or contraindication to drugs or materials required during PCI and the use of the investigational device (including, but not limited to, sirolimus, dual antiplatelet therapy drugs, polyamide, polyurethane, polytetrafluoroethylene, or stainless steel).
ā. Presence of pericardial effusion (moderate or greater), cardiac tamponade, hemodynamically significant left/right shunt, or severe valvular heart disease.
ā. Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.
ā. History of acute myocardial infarction, or documented history of hospitalization for Q-wave infarction.
ā. History of cerebral infarction, intracerebral hemorrhage, transient ischemic attack (TIA), or reversible ischemic neurologic deficit within the past 6 months, or presence of permanent neurological deficit.
ā. Known hemoglobin level below 90 g/L, platelet count below 80Ć10ā¹/L, history of bleeding diathesis or coagulation disorder, or unwillingness to receive blood transfusion.