NCT07354035

The Coronary Sinus Balloon Pump in STEMI

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-02-12
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2026-01-21
• Last updated: 2026-01-21