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NOT YET RECRUITING
NCT07601997
NA

Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)

Sponsor: Myomed Technology (Shaoxing) Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to preliminarily evaluate the safety and feasibility of the transcatheter injectable protein alginate-based hydrogel developed and manufactured by Myomed Technology (Shaoxing) Co., Ltd. in alleviating reperfusion injury in acute STEMI. This is a randomized controlled trial with a blank control group (conventional PCI treatment). A total of 20 patients will be enrolled in a 1:1 ratio into the test group and the control group.

Official title: Clinical Application Study on the Safety and Feasibility of Transcatheter Injectable Protein Alginate-based Hydrogel for Alleviating Reperfusion Injury in Acute STEMI

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-30

Completion Date

2027-04-30

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DEVICE

Injectable protein alginate-based hydrogel

Experimental group: PCI combined with the locally injectable inert material

OTHER

No additional intervention

Conventional PCI procedure

Locations (1)

First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China