Active Heart, Stroke & Blood NIHR-supported project Digestion, Kidneys & Other Organs

Inari VISION Registry - Inari VISION-PE Protocol

Funder NIHR (part of DHSC)
Recipient organisation NIHR University College London Hospitals Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Nov 2029

In plain English

AI plain-English summary

A new registry will track every patient in the UK treated with the FlowTriever device, a catheter that traps and pulls blood clots out of the lungs. Pulmonary embolism—a sudden blockage in a lung artery—kills thousands of people each year. The FlowTriever is already approved for use in Europe, but doctors lack systematic, real-world data on how well it works outside of controlled clinical trials. This registry fills that gap by collecting standard-of-care information on diagnosis, treatment, and 180-day follow-up for all adult patients treated with the device, excluding only those who are pregnant, breastfeeding, or unwilling to consent. If the registry succeeds, it will give clinicians and regulators a clear picture of the device’s performance in everyday hospital practice—not just in ideal trial conditions. That evidence could refine patient selection, improve procedural guidelines, and ultimately reduce deaths from pulmonary embolism. The registry does not dictate how doctors use the device; it simply observes and records what happens when they do.

View original technical description
The purpose of this registry is to collect real-world, standard of care data regarding the clinical use of Inari Medical devices and information about the diagnosis, treatment, and follow-up of pulmonary embolism (PE). The FlowTriever Retrieval/Aspiration System (referred to as “FlowTriever”) is a CE-Marked medical device, and thus commercially available in Europe. The FlowTriever is a device designed to treat pulmonary embolism (PE) in the lung by removing blood clots from blood vessels. The FlowTriever is used to trap the clot and pull it into a catheter so that the clot can be removed from the body. This registry does not specify how the Inari Medical devices will be used during procedures, and decisions regarding a subject’s treatment are not influenced by the registry. The procedure and follow up will be conducted according to a site’s usual care of patients. Participants must: • Be at least 18 years of age • Be treated with an Inari Medical device Patients should not take part in this registry if: • They are currently pregnant or breastfeeding • They do not want to consent to the study, or are not willing to do follow-up visits after the treatment. The duration of a subject's participation in the registry is around 180 days.

Researchers

Conrad Stempel (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Prospective, Multicenter Study of the Indigo Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Product Surveillance Registry - NeuroVascular
Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
Assessment of Long Term, Endovascular AAA Intervention using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis (TGR 23-02AA)
EMBO-PMS: Post Market Surveillance of the IMPEDE Embolization Plug System Protocol CRD 1005

Original classification

Infection, Immunopathology & Immunotherapeutics

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.