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

NCT07601997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • STEMI - ST Elevation Myocardial Infarction

Interventions

DEVICE

Injectable protein alginate-based hydrogel

Experimental group: PCI combined with the locally injectable inert material

OTHER

No additional intervention

Conventional PCI procedure

Sponsors & Collaborators

  • Myomed Technology (Shaoxing) 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
2026-05-30
Primary Completion
2026-10-30
Completion
2027-04-30

Countries

  • China

Study Locations

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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 NCT07601997 on ClinicalTrials.gov