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NOT YET RECRUITING
NCT07082153
NA

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

Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-08-12

Completion Date

2026-03-03

Last Updated

2025-07-24

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.