Ischemic StrokePOSEIDONNCT07760649
A Study to Monitor Safety and Effectiveness of Approved J&J MedTech Devices in the Treatment of Participants With Ischemic Stroke
An observational study of Ischemic Stroke, run by Neuravi Limited.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2026to 31 Dec 2030
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants with angiographic confirmation of acute ischemic stroke who are scheduled to undergo/have undergone mechanical thrombectomy using one or more of the study devices as specified in the protocol.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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).
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Acute Ischemic Stroke | Participants with angiographic confirmation of acute ischemic stroke who are scheduled to undergo/have undergone mechanical thrombectomy using one or more of the study devices will be enrolled. Participants will have the procedure according to the standard of care (SOC) process of the hospital and physician preference. No treatment will be provided by the sponsor as a part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])
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.
Measured: Up to 90 days post-procedure
Secondary outcomes (2)
Percentage of Participants With Modified Rankin Scale (mRS) Score of <=2 or no Worsening at 90 Days
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).
Measured: At 90 days post-procedure
90-Day All-Cause Mortality
All mortality regardless of causes through 90 days post procedure will be reported.
Measured: At 90 Days Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start23 Sep 2026 (estimated)
- Primary completion16 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Neuravi Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neuravi Limited Clinical Trial, Study director, Neuravi Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760649
- Sponsor's protocol ID
- CNV202508
- Acronym
- POSEIDON
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07760649
- Acronym / sponsor ID
- POSEIDON / CNV202508
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Neuravi LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 16 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Acute Ischemic Stroke | – | –Participants with angiographic confirmation of acute ischemic stroke who are scheduled to undergo/have undergone mechanical thrombectomy using one or more of the study devices will be enrolled. Participants will have the procedure according to the standard of care (SOC) process of the hospital and physician preference. No treatment will be provided by the sponsor as a part of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants with angiographic confirmation of acute ischemic stroke who are scheduled to undergo/have undergone mechanical thrombectomy using one or more of the study devices as specified in the protocol.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
90-Day All-Cause Mortality
Time frame: At 90 Days Post-Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neuravi Limited Clinical Trial study director
Neuravi Limited
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Neuravi Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (+ 41 (0) 792923126, MEugeni1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI]) (time frame: Up to 90 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.