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

Starting soon · Not applicable

Conditions studied: Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement

In brief

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.

Key facts

Study ID

NCT07681154

Run by

Flow Medical Solutions, Inc.

People needed

20

Starts

2026-10-01

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Relative contraindications to thrombolytic therapy:
• Severe uncontrolled hypertension at presentation (SBP >180 mmHg or DBP >110 mmHg)
• Major surgery within 3 weeks of baseline CTPA
• Major trauma (non-intracranial) within 3 months of baseline CTPA
• Traumatic or prolonged CPR (>10 minutes) within 3 weeks of baseline CTPA
• Recent internal bleeding within 4 weeks of baseline CTPA
• Noncompressible vascular puncture site(s)
• Active peptic ulcer
• Ischemic stroke more than 3 months prior to baseline CTPA
• Laboratory exclusions (within 6 hours of index procedure, not correctable prior to procedure):

Full record on ClinicalTrials.gov

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