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

NCT07601997 | Not Yet Recruiting

• 1 other identifier: MR-002-CARP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of Major Adverse Events (MAEs) within 30 days after surgery

  Defined as all-cause death, stroke, target vessel myocardial infarction, new-onset severe heart failure, cardiac arrest, cardiogenic shock, sustained ventricular arrhythmia, target vessel revascularization, and any device-related complications.

  within 30 days

• Myocardial Salvage Index (MSI)

  Score range: 0 to 1.0. Higher MSI values indicate better myocardial salvage and superior clinical outcome; lower values indicate smaller salvaged myocardial area and worse outcome.

  7 days, 3 months and 6 months post-procedure.

Secondary Outcomes (21)

• Incidence of serious adverse events and device-related adverse events

  7 days, 30 days, 3 months, and 6 months post-procedure

• Immediate surgical success

  Immediately after the procedure

• AUC of CK-MB and hs-cTnI

  baseline, 1 day, 3 days and 7 days post-procedure

• Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels

  1 day, 3 days and 7days post-procedure

• Concentrations of BNP/NT-proBNP and hsCRP

  baseline, 1 day, 3 days, 7days and 6 months post-procedure

Study Arms (2)

Hydrogel Group

EXPERIMENTAL

Device: Injectable protein alginate-based hydrogel

Blank Control Group

OTHER

Other: No additional intervention

Interventions

Injectable protein alginate-based hydrogel DEVICE

Experimental group: PCI combined with the locally injectable inert material

Hydrogel Group

No additional intervention OTHER

Conventional PCI procedure

Blank Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years;
• Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;
• Ischemic symptoms (e.g., chest pain, precordial discomfort) persist for \>30 minutes, and electrocardiographic findings meet the following criteria: ST-segment (J-point) elevation ≥1.0 mm (i.e., amplitude 0.1 mV) in all conventional leads except leads V2 and V3. For leads V2 and V3, the ST-segment elevation criteria are: ≥2.5 mm in males \<40 years old, ≥2.0 mm in males ≥40 years old, and ≥1.5 mm in females of all ages;
• The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;
• Admission coronary angiography shows that the left anterior descending artery (LAD) has a TIMI flow grade of 0 (complete occlusion), and the TIMI flow grade reaches 3 after stent implantation;
• Able to understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form personally or via a legal representative, and be willing to complete the follow-up in accordance with the protocol requirements.

You may not qualify if:

• Complicated with cardiogenic shock or cardiac arrest; or complicated with acute myocardial infarction mechanical complications requiring surgical or interventional intervention (e.g., ventricular septal perforation, papillary muscle rupture, free wall rupture), or complicated with giant left ventricular aneurysm;
• Previously diagnosed with hypertrophic cardiomyopathy, hemodynamically significant congenital heart disease, severe valvular heart disease, chronic cor pulmonale, chronic heart failure, or with a history of cardiac tamponade, pericarditis, or myocarditis;
• History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;
• Heart failure severity at admission reaches Killip classification Grade III or above;
• Complicated with malignant arrhythmia, complete atrioventricular block, or new-onset complete left bundle branch block (LBBB);
• Diagnosed or suspected aortic dissection;
• Diabetes mellitus with severe complications;
• Complicated with atrial fibrillation and receiving only warfarin treatment, or with a high bleeding risk;
• Received thrombolytic therapy prior to PCI;
• Diameter of the infarct-related artery \< 2 mm or abundant coronary collateral circulation in the risk area;
• Coronary angiography indicates diffuse vascular lesions or severe calcification that may affect the absorption of protein alginate-based hydrogel;
• Severe complications (e.g., coronary artery rupture, perforation, or stent dislodgement) occurring during PCI;
• Received coronary bioresorbable stent implantation;
• Complicated with severe acute infection requiring systemic treatment;

Sponsors & Collaborators

• Myomed Technology (Shaoxing) Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Clinical Medical Director

CONTACT

86-17621666472; contact@myomedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)