Not Yet RecruitingNot Applicable

The First-In-Man Use of Coronary Sinus Balloon Pump in STEMI Patients Treated by Primary PCI

10 participantsStarted 2025-08-12

Plain-language summary

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).

Who can participate

Age range18 Years – 80 Years

SexALL

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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:
✓. 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
✓. Target Lesion Location: Located in the proximal or mid segment of the Left Anterior Descending artery (LAD).
✓. Pre-PCI TIMI Flow: TIMI flow grade 0 or 1 in the target vessel prior to percutaneous coronary intervention (PCI).

Exclusion criteria

✕. Presence of implants or foreign bodies within the coronary sinus.
✕. Target lesion involving the left main coronary artery or ≥50% stenosis in the left main coronary artery.
✕. Known hypersensitivity to medications or devices required during PCI or the investigational device (including but not limited to: rapamycin, polyurethane in dual antiplatelet therapy, PET, or stainless steel).
✕. Pericardial effusion (moderate or larger volume), cardiac tamponade, hemodynamically significant left/right shunts, or severe valvular heart disease.
✕. Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.
✕. History of acute myocardial infarction (AMI) or documented hospitalization for Q-wave infarction.
✕. History of cerebral infarction, intracranial hemorrhage, transient ischemic attack (TIA), or reversible ischemic neurologic deficit within the past 6 months, or permanent neurological deficits.
✕. Hemoglobin \<90 g/L, platelet count \<80×10⁹/L, history of bleeding disorders/coagulopathy, or refusal to accept blood transfusion.

What they're measuring

Device-related procedural complication rate

Timeframe: 24 hours, 30 days post-procedure

Trial details

NCT IDNCT07082153

SponsorShanghai MicroPort Rhythm MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Tingting Wu, M.D.

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

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