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NOT YET RECRUITING
NCT07354035
NA

The Coronary Sinus Balloon Pump in STEMI

Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2026-02-12

Completion Date

2026-06

Last Updated

2026-01-21

Healthy Volunteers

No

Conditions

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