Health TrialsbyHealthPanel

The Coronary Sinus Balloon Pump in STEMI

ConditionSTEMI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai MicroPort Rhythm MedTech Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged ≥18 and ≤80 years, clinically diagnosed with ST-segment elevation myocardial infarction (STEMI).

Left ventricular ejection fraction (LVEF) ≤50% and ≥35% as assessed by echocardiography or left ventriculography prior to PCI.

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.

2 mm (0.2 mV) in men ≥45 years old.

Disqualifiers

Presence of an implant or foreign body within the coronary sinus.

The target lesion involves the left main coronary artery, or there is a ≥50% stenosis in the left main coronary artery.

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).

Presence of pericardial effusion (moderate or greater), cardiac tamponade, hemodynamically significant left/right shunt, or severe valvular heart disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Percutaneous Coronary Intervention (PCI)

    Procedure/Surgery

    Minimally invasive procedures used to open clogged coronary arteries

Treatment groups

177 Participants
are divided into 2 treatment groups
Group A: The coronary sinus balloon pump +PCIExperimental treatment 2 interventions
Group B: Standard PCIPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

Coronary Sinus Pressure (Experimental Group)

Time frame
Immediately post-procedure
4

Change in ST-Segment Elevation

Change in ST-Segment Elevation \[Comparison between post-PCI ECG and baseline\]

Time frame
Immediately post-procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai MicroPort Rhythm MedTech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: