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Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

NCT06935383 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-20

No results posted yet for this study

Summary

The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control.

The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care.

Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months.

If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).

Conditions

  • STEMI (ST Elevation MI)

Interventions

DEVICE

Therapeutic sequence

the required dose of treatment is administered through the CoFI system

DEVICE

Diagnostic sequence

Diagnostic sequence to detect MVO

Sponsors & Collaborators

  • CorFlow Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Giovanni Luigi De Maria · Oxford Heart Centre John Radcliffe Hospital Headley Way - OX3 9DU Oxford United Kingdom

  • Colin Berry · The Royal Golden Jubilee Hospital, Glasgow, Uk

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

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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 NCT06935383 on ClinicalTrials.gov