STEMIREVIVE-FIMNCT07082153
The First-In-Man Use of Coronary Sinus Balloon Pump in STEMI Patients Treated by Primary PCI
A study testing the coronary sinus balloon pump in people with STEMI, run by Shanghai MicroPort Rhythm MedTech Co., Ltd..
Trial 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 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2025to 3 Mar 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
- Clinical 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:
- Acute anterior wall myocardial infarction confirmed by 12-lead ECG, demonstrating ST-segment elevation ≥1 mm (0.1 mV) in ≥2 contiguous precordial leads.
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- For leads V2 or V3:
- Men: ST-segment elevation ≥2 mm (0.2 mV) Women: ST-segment elevation ≥1.5 mm (0.15 mV).
- 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
- Angiography Inclusion Criteria:
- 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).
Who cannot join
- 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.
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- 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.
- Requiring circulatory support or assisted ventilation therapy.
- Cardiac arrest or cardiopulmonary resuscitation (CPR) >5 minutes during pre-procedural baseline or intra-procedural period.
- Unsuitable femoral or jugular venous access.
- Contraindications to cardiac magnetic resonance imaging (CMR), including claustrophobia, CMR-incompatible implants/foreign bodies, or gadolinium contrast allergy/intolerance.
- Prior coronary artery bypass grafting (CABG).
- Visible collateral circulation formation distal to the target lesion in the target vessel.
- Current participation in another investigational drug/device trial (prior to primary endpoint completion) or planned enrollment in another trial within 12 months post-procedure.
- Severe renal dysfunction (eGFR <30 mL/min/1.73m² by MDRD equation*) or ongoing hemodialysis.
- Active malignancy treatment within the past 12 months.
- Chronic obstructive pulmonary disease (COPD) requiring home oxygen therapy or chronic steroid therapy.
- Impaired consciousness during PCI, cardiogenic shock (persistent SBP ≤90 mmHg despite conservative therapy), or pulmonary edema (peripheral SpO₂ <90% with rales).
- Any vascular PCI performed within 7 days prior to hospitalization.
- Fibrinolytic therapy administered within 24 hours prior to hospitalization.
- Non-target lesions requiring treatment during index PCI or within 1 week post-procedure (excluding LAD and its branches).
- Pregnancy, lactation, or female subjects planning pregnancy within 1 year post-procedure unable to complete follow-up.
- Poor protocol compliance per investigator's judgment, or subjects deemed ineligible due to other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kefei Do, M.D. contact
About this study
Official title: A Prospective, Multicenter Clinical trIal in Evaluating the Safety and Efficacy of the Coronary Sinus Balloon Pump for the First-In-Man Use in STEMI Patients
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.
- Conditions
- STEMI
- Being tested
- the coronary sinus balloon pump
- Keywords
- STEMI, the coronary sinus balloon pump
- 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.
| Study group | Role | What they receive |
|---|---|---|
| The coronary sinus balloon pump | Experimental | Subjects in experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rhythm Co. Ltd. Receives: Device: the coronary sinus balloon pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 5 days, 30 days, 4 months, 6 months, 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.
- First posted24 Jul 2025
- Study start12 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082153
- Sponsor's protocol ID
- REVIVE-FIM
- Acronym
- REVIVE-FIM
- Status last verified
- Jul 2025
- First submitted
- 12 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical trIal in Evaluating the Safety and Efficacy of the Coronary Sinus Balloon Pump for the First-In-Man Use in STEMI Patients
- ClinicalTrials.gov ID
- NCT07082153
- Acronym / sponsor ID
- REVIVE-FIM / REVIVE-FIM
- Conditions
- STEMI
- Keywords
- STEMI, the coronary sinus balloon pump
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The coronary sinus balloon pump | Experimental | Device: the coronary sinus balloon pumpSubjects in experimental group will be treated with the coronary sinus balloon pump manufactured by Shanghai Microport Rhythm Co. Ltd. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical 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:
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the coronary sinus balloon pumpThe 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. | Device | The coronary sinus balloon pump |
Primary outcome
Device-related procedural complication rate
Time frame: 24 hours, 30 days post-procedure
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)
1 secondary outcome
MACCE (Major Adverse Cardiac and Cerebrovascular Events)
Time frame: 5 days, 30 days, 4 months, 6 months, 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kefei Do, M.D. contact
Questions about this trial
What is this clinical trial studying?
A study testing the coronary sinus balloon pump 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 24 Jul 2025. 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. 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, M.D. (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?
Device-related procedural complication rate (time frame: 24 hours, 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.