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

NCT07681154 | Not Yet Recruiting

• 1 other identifier: FM095
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

catheter directed thrombolysis, lysis, lytics, thrombolysis

Outcome Measures

Primary Outcomes (2)

• Incidence of device-related serious adverse events (SAEs)

  Number of participants experiencing one or more serious adverse events assessed as related to the study device.

  72 hours post procedure

• Successful device deployment and thrombolytic infusion

  Proportion of participants in whom the Flow Medical scaffold is successfully deployed and expanded within the target pulmonary artery, with confirmed initiation and maintenance of thrombolytic infusion through the device for the protocol-specified duration.

  Index Procedure through 24 hours post

Study Arms (1)

Catheter-Directed Thrombolysis (Flow Medical Catheter)

EXPERIMENTAL

All participants undergo catheter-directed thrombolysis with the Flow Medical Catheter for treatment of acute intermediate-risk pulmonary embolism. This is a single-arm study; all enrolled participants receive the same study intervention.

Device: Thrombolysis Catheter

Interventions

Thrombolysis Catheter DEVICE

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.

Also known as: PE Catheter, Catheter Directed Thrombolysis

Catheter-Directed Thrombolysis (Flow Medical Catheter)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet ALL of the following criteria to be eligible:
• Age 18 to 75 years, inclusive.
• Clinical signs and/or symptoms consistent with acute PE with symptom onset ≤14 days prior to baseline CTPA.
• CTPA demonstrating acute PE with a filling defect in at least one main or lobar pulmonary artery.
• RV/LV diameter ratio ≥0.9 on baseline CTPA (site read acceptable for eligibility determination).
• Medically eligible for CDT and standard anticoagulation per institutional guidelines and the treating investigator's judgment.
• Willing and able to provide written informed consent and comply with all study procedures and follow-up requirements.

You may not qualify if:

• Subjects meeting ANY of the following criteria are not eligible:
• High-risk (massive) PE: Sustained SBP \<90 mmHg for ≥15 consecutive minutes, \>40 mmHg drop from baseline, vasopressor requirement, or cardiac arrest requiring cardiopulmonary resuscitation during the immediate hospitalization.
• Respiratory insufficiency: FiO₂ requirement \>40% or \>6 LPM supplemental oxygen to maintain SpO₂ \>90%.
• Prior PE: Prior PE ≤180 days from index procedure.
• Absolute contraindications to thrombolytic therapy:
• Any prior intracranial hemorrhage (no time limit)
• Known structural cerebrovascular lesion or arteriovenous malformation (no time limit)
• Known malignant intracranial neoplasm (no time limit)
• Ischemic stroke or TIA within 3 months of baseline CTPA
• Intracranial or intraspinal surgery within 2 months of baseline CTPA
• Significant closed-head or facial trauma within 3 months of baseline CTPA
• Suspected aortic dissection
• Active bleeding or bleeding diathesis (excluding menses)
• Active intracranial or intraspinal disease
• Irreversible neurological compromise

Sponsors & Collaborators

• Flow Medical Solutions, Inc.: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Miguel Naranjo, MD

  Hospital Regional de Talca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Wylie

CONTACT

+1 650 224 5810; clinical@flowmedical.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06