Registry for patients treated with Inari Medical devices for pulmonary embolism
Inari VISION Registry
This study collects information from patients treated for pulmonary embolism using Inari Medical devices to see how well they work and how safe they are in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inari Medical Industry-sponsored |
| Locations | 10 sites (Ancona and 9 other locations) |
| Trial ID | NCT06600542 on ClinicalTrials.gov |
What this trial studies
This registry collects data on patients who have received treatment for pulmonary embolism using Inari Medical devices. It is a global, prospective, non-randomized, multicenter observational study aimed at gathering post-market data on the effectiveness and safety of these devices. Patients who consent and meet eligibility criteria will be monitored for outcomes related to their treatment. The registry aims to enhance understanding of the devices' performance in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who have received treatment with an eligible Inari Medical device.
Not a fit: Patients who are pregnant, breastfeeding, or currently participating in another conflicting study may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of Inari Medical devices, potentially improving treatment protocols for pulmonary embolism.
How similar studies have performed: While this registry is observational and focuses on post-market data collection, similar studies have shown success in providing valuable insights into device performance and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willing and able to provide informed consent per institution and geographical requirements 2. Has received treatment with an eligible Inari Medical device. NOTE: If patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure. 3. Currently within enrollment window relative to their procedure 4. Age ≥ 18 years Exclusion Criteria: 1. Is or will be inaccessible for registry follow-up 2. Meets exclusion criteria required by local requirements 3. Current or planned participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this registry 4. Is pregnant or breastfeeding at the time of enrollment
Where this trial is running
Ancona and 9 other locations
- Azienda Ospedaliero Universitaria delle Marche — Ancona, Italy (Recruiting)
- Santa Marta Hospital — Lisbon, Portugal (Recruiting)
- Southmead Hospital Bristol — Bristol, United Kingdom (Recruiting)
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (Recruiting)
- Northwick Park Hospital — London, United Kingdom (Recruiting)
- Royal Free Hospital — London, United Kingdom (Recruiting)
- Royal London — London, United Kingdom (Recruiting)
- UCLH University College London Hospital — London, United Kingdom (Recruiting)
- Royal Victoria Infirmary — Newcastle, United Kingdom (Recruiting)
- Great Western Hospital — Swindon, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Ida Nelson
- Email: ida.nelson@inarimedical.com
- Phone: 46 707 723010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.