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Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism

NCT07681154 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-02

No results posted yet for this study

Summary

This is a pilot study of the Flow Medical Catheter, a catheter-based device used to deliver clot-dissolving medication directly to a blood clot in the lungs (pulmonary embolism). The study evaluates whether the device can be used safely and as intended in adults with intermediate-risk acute pulmonary embolism. All participants receive treatment with the study device; there is no comparison group.

Conditions

  • Pulmonary Embolism (PE)
  • Pulmonary Embolism With Right Ventricle Enlargement

Interventions

DEVICE

Thrombolysis Catheter

Catheter-directed thrombolysis is performed using the Flow Medical Catheter to deliver a thrombolytic agent directly into the pulmonary arteries. The device is positioned at the target site, and thrombolytic infusion is delivered per the study protocol.

Sponsors & Collaborators

  • Flow Medical Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Miguel Naranjo, MD · Hospital Regional de Talca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-05-31
Completion
2027-06-30

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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 NCT07681154 on ClinicalTrials.gov