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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07760649

Acronym

POSEIDON

Enrollment

5000

Registered

2026-08-12

Start date

2026-08-10

Completion date

2030-12-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])	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

Measure	Time frame	Description
Percentage of Participants With Modified Rankin Scale (mRS) Score of <=2 or no Worsening at 90 Days	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	At 90 Days Post-Procedure	All mortality regardless of causes through 90 days post procedure will be reported.

Countries

Germany, Switzerland

Contacts

CONTACTStudy Contact

MEugeni1@its.jnj.com+ 41 (0) 792923126

STUDY_DIRECTORNeuravi Limited Clinical Trial

Neuravi Limited

Outcome results