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The Coronary Sinus Balloon Pump in STEMI

NCT07354035 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-01-21

No results posted yet for this study

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 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

Interventions

DEVICE

The 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.

PROCEDURE

Percutaneous Coronary Intervention (PCI)

Minimally invasive procedures used to open clogged coronary arteries

Sponsors & Collaborators

  • Shanghai MicroPort Rhythm MedTech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-12
Primary Completion
2026-05-31
Completion
2026-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07354035 on ClinicalTrials.gov