Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
United States, Austria, Poland123 participantsStarted 2024-10-15
Plain-language summary
This 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 acute 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 or subject's legally authorized representative (LAR) - applicable for US 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)
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
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio