The Coronary Sinus Balloon Pump in STEMI

NCT07354035 | Not Yet Recruiting

• 1 other identifier: AMD-D-005
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

STEMI

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  at 30 days post-procedure

Secondary Outcomes (18)

• Device Success Rate (Experimental Group)

  Immediately post-procedure

• Procedure Success Rate (Experimental Group)

  Immediately post-procedure

• Coronary Sinus Pressure (Experimental Group)

  Immediately post-procedure

• Change in ST-Segment Elevation

  Immediately post-procedure

• Incidence of Device-Related Procedural Complications (Experimental Group)

  Immediately post-procedure

Study Arms (2)

The coronary sinus balloon pump +PCI

EXPERIMENTAL

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)

Standard PCI

PLACEBO COMPARATOR

Procedure: Percutaneous Coronary Intervention (PCI)

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

Minimally invasive procedures used to open clogged coronary arteries

Standard PCI; The coronary sinus balloon pump +PCI

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.

The coronary sinus balloon pump +PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 ECG. For leads V2 or V3, the following gender- and age-specific cutoffs apply:
• mm (0.2 mV) in men ≥45 years old.
• mm (0.25 mV) in men \<40 years old.
• mm (0.15 mV) in women.
• Subject is eligible for primary percutaneous coronary intervention (primary PCI).
• 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.
• The target lesion is located in the proximal or mid segment of the left anterior descending artery (LAD).
• TIMI flow grade of the target vessel is 0, 1, or 2 prior to PCI treatment.

You may not qualify if:

• 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.
• Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.
• History of acute myocardial infarction, or documented history of hospitalization for Q-wave infarction.
• 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.
• Known hemoglobin level below 90 g/L, platelet count below 80×10⁹/L, history of bleeding diathesis or coagulation disorder, or unwillingness to receive blood transfusion.
• Subjects requiring circulatory support or assisted ventilation.
• Subjects experiencing cardiac arrest or cardiopulmonary resuscitation (CPR) for more than 5 minutes preoperatively (baseline) or intraoperatively.
• Subjects unsuitable for femoral or jugular venous access.
• Known contraindications to cardiac magnetic resonance imaging (CMR), such as claustrophobia, presence of non-CMR compatible foreign bodies or implants, or allergy/intolerance to gadolinium-based contrast agents.
• Prior coronary artery bypass graft (CABG) surgery.
• Visible well-developed collateral circulation distal to the target lesion in the target vessel.
• Current participation in another clinical drug or device study where the primary endpoint has not been reached, or planned participation in another investigational drug or device clinical trial within 12 months after the baseline procedure.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Tingting Wu

CONTACT

0086-021-38954600; TingTing.Wu2@microport.com

Kefei Do

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 21, 2026
• Study Start: February 12, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01