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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The coronary sinus balloon pump | Experimental | Subjects in experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rhythm Co. Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the coronary sinus balloon pump | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related procedural complication rate | Device-related procedural complication rate [24 hours, 30 days post-procedure]: Complications include:
| 24 hours, 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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]:
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate (cardiac, vascular, non-vascular) | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure | |
| Heart failure hospitalization rate | 30 days, 4 months, 6 months, 12 months post-procedure |
Inclusion Criteria:
Clinical inclusion criteria:
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.
Electrocardiographic Evidence:
Men: ST-segment elevation ≥2 mm (0.2 mV) Women: ST-segment elevation ≥1.5 mm (0.15 mV).
PCI Eligibility: Candidate for primary percutaneous coronary intervention (PCI).
Subjects who can understand the purpose of the trial, voluntarily participate and acknowledge the risks and benefits described in the informed consent document by signing the informed consent form, and can conscientiously complete clinical follow-up as required
Angiography Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Wu, M.D. | Contact | 0086-021-38954600 | TingTing.Wu2@microport.com | |
| Kefei Do, M.D. | Contact |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| New-onset/worsening heart failure rate | 30 days, 4 months, 6 months, 12 months post-procedure |
| MI incidence | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Revascularization rate | Revascularization rate (target lesion, target vessel, any coronary) | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Stent thrombosis rate | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Major bleeding rate (BARC type 3-5) | Based on the Bleeding Academic Research Consortium (BARC) Scale, type 5 is more serious. | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Stroke incidence | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Adverse event (AE)/Serious adverse event (SAE) rate | Periprocedural, 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Device deficiency rate | Periprocedural, 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Device success rate | Successful device delivery to the coronary sinus, deployment, and completion of therapy | Periprocedural |
| Procedure success rate | PCI success without CSBP-related adverse events (based on device success) | Periprocedural |
| Coronary sinus pressure | intra-procedure |
| MRI measurement of infarct size | 5 days, 4 months post-procedure |
| Angina severity | 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. | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Changes in quality of life | 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) | 5 days, 30 days, 4 months, 6 months, 12 months post-procedure |
| Assessment of left ventricular function | Left ventricular function assessed by echocardiography | 5 days, 4 months post-procedure |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |