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STEMIREVIVE-RCTNCT07354035

The Coronary Sinus Balloon Pump in STEMI

A study testing The coronary sinus balloon pump and Percutaneous Coronary Intervention (PCI) in people with STEMI, run by Shanghai MicroPort Rhythm MedTech Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
STEMI
What is being tested?
The coronary sinus balloon pump and Percutaneous Coronary Intervention (PCI)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
177 participants
Where
No sites listed yet
Study dates
12 Feb 2026to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • 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:
  • 2 mm (0.2 mV) in men ≥45 years old.
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  • 2.5 mm (0.25 mV) in men <40 years old.
  • 1.5 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.
  • Angiographic Inclusion Criteria:
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Known severe renal disease (estimated glomerular filtration rate (eGFR) <30 mL/(min·1.73m²) as calculated by the MDRD formula*) or undergoing hemodialysis.
  • History of treatment for malignancy within the past 12 months.
  • Subjects with chronic obstructive pulmonary disease (COPD) who are on home oxygen therapy or receiving chronic steroid therapy.
  • Impaired consciousness during PCI, cardiogenic shock (persistent systolic blood pressure ≤90 mmHg despite conservative treatment), or pulmonary edema (peripheral oxygen saturation <90% with rales).
  • Any vascular PCI treatment received within 1 week prior to enrollment.
  • Fibrinolytic therapy received within 24 hours prior to enrollment.
  • -target lesions in vessels other than the left anterior descending artery and its branches requiring treatment during this PCI or within one week thereafter.
  • Known pregnancy or breastfeeding, or female subjects planning pregnancy within 1 year post-procedure and unable to complete follow-up as required.
  • Subjects judged by the investigator to have poor compliance and unable to complete the study as required, or any other reason the investigator deems the subject unsuitable for enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tingting Wu contact

0086-021-38954600

TingTing.Wu2@microport.com

Kefei Do contact

About this study

Official title: A Prospective, Randomized, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Use of Coronary Sinus Balloon Pump Along With PCI in STEMI Patients

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
Being tested
The coronary sinus balloon pump, Percutaneous Coronary Intervention (PCI)
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The coronary sinus balloon pumpDevice

    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 or surgery

    Minimally invasive procedures used to open clogged coronary arteries

Study groups in NCT07354035
Study groupRoleWhat they receive
The coronary sinus balloon pump +PCIExperimentalSubjects in the experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rotapace Co. Ltd.
Receives: Device: The coronary sinus balloon pump; Procedure: Percutaneous Coronary Intervention (PCI)
Standard PCIPlacebo comparatorNot described
Receives: Procedure: Percutaneous Coronary Intervention (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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

    Measured: at 30 days post-procedure

Secondary outcomes (18)

  1. Device Success Rate (Experimental Group)

    Successful delivery and deployment of the device to the coronary sinus and completion of the intended procedure

    Measured: 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

    Measured: Immediately post-procedure

  3. Coronary Sinus Pressure (Experimental Group)

    Measured: Immediately post-procedure

  4. Change in ST-Segment Elevation

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

    Measured: Immediately post-procedure

  5. Incidence of Device-Related Procedural Complications (Experimental Group)

    Procedural Complications are defined as: Access site complications (including access site bleeding of BARC Type 3-5, access site infection requiring oral or intravenous antibiotics, access site complication requiring surgical intervention), coronary sinus dissection or perforation requiring intervention or surgical repair, pericardial effusion or cardiac tamponade requiring intervention or surgical treatment, thrombosis or thromboembolism, and stroke. The relatedness of a procedural complication to the device must be adjudicated by the Clinical Events Committee (CEC).

    Measured: Immediately post-procedure

  6. Death (cardiac, vascular, non-vascular)

    Rate of death (cardiac, vascular, non-vascular), as adjudicated by the Clinical Events Committee (CEC)

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  7. Rate of heart failure hospitalization

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  8. Incidence of new-onset or worsening heart failure

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  9. Incidence of myocardial infarction

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  10. Incidence of revascularization (target lesion, target vessel, any coronary)

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  11. Incidence of stent thrombosis

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  12. Incidence of major bleeding events

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  13. Incidence of stroke

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  14. Severity of angina

    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.

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  15. Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion

    Ventricular tachycardia or ventricular fibrillation requiring defibrillation or cardioversion as adjudicated by the CEC

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  16. EQ-5D quality of life score

    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)

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  17. Incidence of adverse events and serious adverse events

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

  18. Incidence of device deficiencies (Experimental Group only)

    Measured: at 5 days, 30 days, 6 months, and 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start12 Feb 2026 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07354035
Sponsor's protocol ID
AMD-D-005
Acronym
REVIVE-RCT
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
21 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The coronary sinus balloon pump and Percutaneous Coronary Intervention (PCI) in people with STEMI, run by Shanghai MicroPort Rhythm MedTech Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tingting Wu (0086-021-38954600, TingTing.Wu2@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarct size (time frame: 5 days after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07354035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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