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

NCT07082153 | Not Yet Recruiting

• 1 other identifier: REVIVE-FIM
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

STEMI

Keywords

STEMI; the coronary sinus balloon pump

Outcome Measures

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)

  24 hours, 30 days post-procedure

Secondary Outcomes (1)

• MACCE (Major Adverse Cardiac and Cerebrovascular Events)

  5 days, 30 days, 4 months, 6 months, 12 months post-procedure

Other Outcomes (17)

• All-cause mortality rate (cardiac, vascular, non-vascular)

  5 days, 30 days, 4 months, 6 months, 12 months post-procedure

• Heart failure hospitalization rate

  30 days, 4 months, 6 months, 12 months post-procedure

• New-onset/worsening heart failure rate

  30 days, 4 months, 6 months, 12 months post-procedure

Study Arms (1)

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.

Device: the coronary sinus balloon pump

Interventions

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

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 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.
• 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
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tingting Wu, M.D.

CONTACT

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

Kefei Do, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 24, 2025
• Study Start: August 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 3, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07