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.
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).
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.
Any prior intracranial hemorrhage (no time limit)
Single group
Thrombolysis Catheter
DeviceCatheter-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.
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.
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.
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