A Study to Monitor Safety and Effectiveness of Approved J&J MedTech Devices in the Treatment of Participants With Ischemic Stroke

The purpose of this study is to collect medical information to monitor the ongoing safety of the J&J MedTech devices and to understand how well they work when routinely used to treat participants with acute ischemic stroke (a condition caused by a blocked blood vessel in the brain).

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant is 18 years of age or older at the time of consent
Informed Consent has been provided by the participant or the participants' legally authorized representative (LAR)
Participants with angiographic confirmation of acute ischemic stroke
A clinical decision has been made to treat the participant with an eligible Johnson & Johnson MedTech neuro-thrombectomy device independently and prior to enrollment in the study

Exclusion criteria

Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
Current involvement in an investigational (drug, device, etcetera) clinical study that may confound study endpoints. Sponsor approval is required prior to enrollment

Treatment and study plan

Primary outcomes

Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])

Time frame: Up to 90 days post-procedure

Revascularization is defined as achieving a specific minimum mTICI score, such as 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke with grades as follows: mTICI 0 = no perfusion; mTICI 1 = penetration but not perfusion; mTICI 2a = some perfusion with distal branch filling of less than (<)50 percent (%) of territory visualized; mTICI 2b = substantial perfusion with distal branch filling of >=50% of territory visualized; mTICI 2c = near-complete perfusion; mTICI 3 = complete perfusion.

Secondary outcomes

Percentage of Participants With Modified Rankin Scale (mRS) Score of <=2 or no Worsening at 90 Days

Time frame: At 90 days post-procedure

Percentage of participants with mRS score of <=2, or no worsening from baseline, at 90 days will be reported. The mRS is a commonly used 7-point disability scale with possible scores ranging from 0 (no symptoms) to 6 (Death).
90-Day All-Cause Mortality

Time frame: At 90 Days Post-Procedure

All mortality regardless of causes through 90 days post procedure will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

+ 41 (0) 792923126

Sponsors and collaborators

Lead sponsor

Neuravi Limited

Industry

Registry information

Official study title

A Post-market Observational Study to Monitor Safety and Effectiveness in the Treatment of Patients With Ischemic Stroke Using Commercially Approved J&J MedTech Devices Optimized for Neurovascular Thrombectomy

Acronym: POSEIDON

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Aug 12, 2026
Registry last updated: Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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