VISION-PE Registry
Research type
Research Study
Full title
Inari VISION Registry - Inari VISION-PE Protocol
IRAS ID
346369
Contact name
Ida Nelson
Contact email
Sponsor organisation
Inari Medical Europe GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
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.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0799
Date of REC Opinion
28 Oct 2024
REC opinion
Favourable Opinion