Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Austria, Poland10 participantsStarted 2024-09-10
Plain-language summary
This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.
Who can participate
Age range
18 Years – 79 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 years \< 80 years
. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
. RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined).
. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures
. Subject is willing and able to comply with all clinical investigation plan required follow-up visits
Exclusion criteria
. Thrombolytic use within 30 days of baseline CTA
. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
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.
1This trial for pulmonary embolism has already been completed — has the data been published yet, and if so, what did it show about changes in the right ventricle-to-left ventricle ratio after the procedure?
2Since the trial tracked Major Adverse Events as a primary outcome, what kinds of serious complications were reported, and how does that safety profile compare to the standard treatment you would recommend for me?
3The trial name mentions 'selective pulmonary-artery intervention' — can you explain what that procedure actually involves and how it differs from clot-busting medications or other approaches I might already qualify for?
4Because this trial is listed under Phase NA rather than a standard numbered phase, what does that mean for how much is actually known about how well this intervention works, and should that affect my thinking about similar treatments?
5Given that my heart is under strain from the clot, how would my own RV/LV ratio compare to the patients in this trial, and does that help you decide whether this type of intervention might be worth discussing for my situation?
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
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio