Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary… (NCT07681154) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
20 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of device-related serious adverse events (SAEs)
Timeframe: 72 hours post procedure
2
Successful device deployment and thrombolytic infusion
. 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