RecruitingNot Applicable

The PERSEVERE Study

United States, France, Germany200 participantsStarted 2024-12-16

Plain-language summary

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Who can participate

Age range

18 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 at enrollment ≥18 years
. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
. High-risk class of acute PE
. RV dysfunction, as defined RV/LV ratio ≥1.0
. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

Exclusion criteria

. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
. Recent stroke (\<14 days)
. Recent cranial or spinal surgery (\<14 days)

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

Composite clinical endpoint of the following adjudicated events:

Timeframe: The earlier of initial hospital discharge or 7 days after randomization

Trial details

NCT IDNCT06588634

SponsorInari Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Tine Devolder

+32 476 53 88 05 tine.devolder@inarimedical.com

View on ClinicalTrials.gov More Pulmonary Embolism trials