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Not yet recruitingNCT07082153REVIVE-FIMUpdated Jul 24, 2025

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

An interventional study of the coronary sinus balloon pump 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 2025-07-24.

Sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the detailed description

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.

02

Conditions studied

  • STEMI

Keywords

  • STEMI
  • the coronary sinus balloon pump
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Clinical inclusion criteria：

  1. Subjects aged ≥18 and ≤80 years with clinically confirmed ST-segment elevation myocardial infarction (STEMI).
  2. Left Ventricular Dysfunction: Left ventricular ejection fraction (LVEF) ≤50% assessed by pre-PCI echocardiography or left ventriculography.
  3. 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.

  4. Electrocardiographic Evidence:

    • Acute anterior wall myocardial infarction confirmed by 12-lead ECG, demonstrating ST-segment elevation ≥1 mm (0.1 mV) in ≥2 contiguous precordial leads.
    • For leads V2 or V3:

    Men: ST-segment elevation ≥2 mm (0.2 mV) Women: ST-segment elevation ≥1.5 mm (0.15 mV).

  5. PCI Eligibility: Candidate for primary percutaneous coronary intervention (PCI).
  6. 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:

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of implants or foreign bodies within the coronary sinus.
  2. Target lesion involving the left main coronary artery or ≥50% stenosis in the left main coronary artery.
  3. 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).
  4. Pericardial effusion (moderate or larger volume), cardiac tamponade, hemodynamically significant left/right shunts, or severe valvular heart disease.
  5. Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.
  6. History of acute myocardial infarction (AMI) or documented hospitalization for Q-wave infarction.
  7. History of cerebral infarction, intracranial hemorrhage, transient ischemic attack (TIA), or reversible ischemic neurologic deficit within the past 6 months, or permanent neurological deficits.
  8. Hemoglobin \<90 g/L, platelet count \<80×10⁹/L, history of bleeding disorders/coagulopathy, or refusal to accept blood transfusion.
  9. Requiring circulatory support or assisted ventilation therapy.
  10. Cardiac arrest or cardiopulmonary resuscitation (CPR) >5 minutes during pre-procedural baseline or intra-procedural period.
  11. Unsuitable femoral or jugular venous access.
  12. Contraindications to cardiac magnetic resonance imaging (CMR), including claustrophobia, CMR-incompatible implants/foreign bodies, or gadolinium contrast allergy/intolerance.
  13. Prior coronary artery bypass grafting (CABG).
  14. Visible collateral circulation formation distal to the target lesion in the target vessel.
  15. Current participation in another investigational drug/device trial (prior to primary endpoint completion) or planned enrollment in another trial within 12 months post-procedure.
  16. Severe renal dysfunction (eGFR \<30 mL/min/1.73m² by MDRD equation*) or ongoing hemodialysis.
  17. Active malignancy treatment within the past 12 months.
  18. Chronic obstructive pulmonary disease (COPD) requiring home oxygen therapy or chronic steroid therapy.
  19. Impaired consciousness during PCI, cardiogenic shock (persistent SBP ≤90 mmHg despite conservative therapy), or pulmonary edema (peripheral SpO₂ \<90% with rales).
  20. Any vascular PCI performed within 7 days prior to hospitalization.
  21. Fibrinolytic therapy administered within 24 hours prior to hospitalization.
  22. Non-target lesions requiring treatment during index PCI or within 1 week post-procedure (excluding LAD and its branches).
  23. Pregnancy, lactation, or female subjects planning pregnancy within 1 year post-procedure unable to complete follow-up.
  24. Poor protocol compliance per investigator's judgment, or subjects deemed ineligible due to other reasons.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    The coronary sinus balloon pump

    Subjects in experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rhythm Co. Ltd.

    Device: the coronary sinus balloon pump

Interventions

  • Devicethe coronary sinus balloon pump

    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.

05

What researchers measure

Primary outcomes

  1. Device-related procedural complication rate

    Device-related procedural complication rate \[24 hours, 30 days post-procedure\]: Complications include: * Access site complications: BARC type 3-5 bleeding; infection requiring oral/intravenous antibiotics; or access site complications requiring surgical intervention * Coronary sinus dissection or perforation requiring interventional/surgical treatment * Pericardial effusion or cardiac tamponade requiring interventional/surgical treatment * Thrombosis or embolism * Stroke (Note: CEC adjudication required to determine device-relatedness)

    Time frame: 24 hours, 30 days post-procedure

Secondary outcomes

  1. MACCE (Major Adverse Cardiac and Cerebrovascular Events)

    MACCE (Major Adverse Cardiac and Cerebrovascular Events) \[5 days, 30 days, 4 months, 6 months, 12 months post-procedure\]: * Cardiac death * Hospitalization for heart failure * New-onset heart failure or worsening of pre-existing heart failure * Ventricular tachycardia/fibrillation requiring cardioversion/defibrillation * Myocardial infarction (MI) * Target vessel revascularization (TVR) * Stent thrombosis * Major bleeding (BARC type 3-5) * Stroke

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

Other outcomes

  1. All-cause mortality rate (cardiac, vascular, non-vascular)

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  2. Heart failure hospitalization rate

    Time frame: 30 days, 4 months, 6 months, 12 months post-procedure

  3. New-onset/worsening heart failure rate

    Time frame: 30 days, 4 months, 6 months, 12 months post-procedure

  4. MI incidence

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  5. Revascularization rate

    Revascularization rate (target lesion, target vessel, any coronary)

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  6. Stent thrombosis rate

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  7. Major bleeding rate (BARC type 3-5)

    Based on the Bleeding Academic Research Consortium (BARC) Scale, type 5 is more serious.

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  8. Stroke incidence

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  9. Adverse event (AE)/Serious adverse event (SAE) rate

    Time frame: Periprocedural, 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  10. Device deficiency rate

    Time frame: Periprocedural, 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  11. Device success rate

    Successful device delivery to the coronary sinus, deployment, and completion of therapy

    Time frame: Periprocedural

  12. Procedure success rate

    PCI success without CSBP-related adverse events (based on device success)

    Time frame: Periprocedural

  13. Coronary sinus pressure

    Time frame: intra-procedure

  14. MRI measurement of infarct size

    Time frame: 5 days, 4 months post-procedure

  15. 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.

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  16. 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)

    Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure

  17. Assessment of left ventricular function

    Left ventricular function assessed by echocardiography

    Time frame: 5 days, 4 months post-procedure

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07082153
Lead sponsor
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Aug 12, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Mar 3, 2026 (estimated)
Last update
Jul 24, 2025

Study contacts

Tingting Wu, M.D.
Contact
TingTing.Wu2@microport.com
0086-021-38954600
Kefei Do, M.D.
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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