An interventional study of The coronary sinus balloon pump and Percutaneous Coronary Intervention (PCI) in STEMI, sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd. (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
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).
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 177 is close to the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Shanghai MicroPort Rhythm MedTech Co., Ltd. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Inclusion Criteria:
Electrocardiographic evidence of acute anterior wall myocardial infarction, defined as ST-segment elevation ≥1 mm (0.1 mV) in at least two contiguous precordial leads on a 12-lead . For leads V2 or V3, the following gender- and age-specific cutoffs apply:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in the experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rotapace Co. Ltd.
Device: The coronary sinus balloon pump · Procedure: Percutaneous Coronary Intervention (PCI)
Procedure: Percutaneous Coronary Intervention (PCI)
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.
Minimally invasive procedures used to open clogged coronary arteries
Myocardial infarct size
Myocardial infarct size is measured by cardiac magnetic resonance (CMR) 5 days after the procedure, expressed as a percentage of left ventricular mass (%LV).
Time frame: 5 days after the procedure
Incidence of Major Adverse Events (MAE) (Experimental Group)
Major Adverse Events (MAE) include: All-cause death Myocardial infarction Target vessel revascularization Hospitalization for heart failure New onset or worsening heart failure Coronary sinus dissection or perforation requiring intervention or surgical repair Thrombosis or thromboembolism Stroke Major bleeding (BARC Type 3\~5) Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion
Time frame: at 30 days post-procedure
Device Success Rate (Experimental Group)
Successful delivery and deployment of the device to the coronary sinus and completion of the intended procedure
Time frame: Immediately post-procedure
Procedure Success Rate (Experimental Group)
Achievement of PCI success based on device success, without the occurrence of any CSBP-related adverse events
Time frame: Immediately post-procedure
Coronary Sinus Pressure (Experimental Group)
Time frame: Immediately post-procedure
Change in ST-Segment Elevation
Change in ST-Segment Elevation \[Comparison between post-PCI ECG and baseline\]
Time frame: Immediately post-procedure
Incidence of Device-Related Procedural Complications (Experimental Group)
Procedural Complications are defined as: Access site complications (including access site bleeding of BARC Type 3-5, access site infection requiring oral or intravenous antibiotics, access site complication requiring surgical intervention), coronary sinus dissection or perforation requiring intervention or surgical repair, pericardial effusion or cardiac tamponade requiring intervention or surgical treatment, thrombosis or thromboembolism, and stroke. The relatedness of a procedural complication to the device must be adjudicated by the Clinical Events Committee (CEC).
Time frame: Immediately post-procedure
Death (cardiac, vascular, non-vascular)
Rate of death (cardiac, vascular, non-vascular), as adjudicated by the Clinical Events Committee (CEC)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Rate of heart failure hospitalization
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of new-onset or worsening heart failure
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of myocardial infarction
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of revascularization (target lesion, target vessel, any coronary)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of stent thrombosis
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of major bleeding events
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of stroke
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Severity of angina
Angina severity (classified according to the Canadian Cardiovascular Society Classification of Angina Pectoris) is assessed by the level of physical activity that triggers the chest pain. And the lower the level that triggers the chest pain, the more serious angina.
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion
Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion as adjudicated by the CEC
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
EQ-5D quality of life score
Changes in quality of life measured by EQ-5D (assessed by the following five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) (scale of 0-100: higher score better)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of adverse events and serious adverse events
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
Incidence of device deficiencies (Experimental Group only)
Time frame: at 5 days, 30 days, 6 months, and 12 months post-procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ST Elevation Myocardial Infarction →
Shanghai MicroPort Rhythm MedTech Co., Ltd. →