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One-Pass clot removal device tested in major stroke study

NCT ID NCT04562194

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called the NeVa stent retriever to see how well it can remove blood clots in people having a severe stroke. The goal is to restore blood flow to the brain in a single pass. The study will enroll 600 adults who are already scheduled to have this procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment. 1. Age ≥18 2. NIHSS score ≥ 6 3. Pre-stroke mRS score ≤ 1 4. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA. 5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\]) 6. Imaging Inclusion Criteria: The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines: * ASPECTS 6-10 if treatment started 0-6 hours from TLKW * ASPECTS 8-10 if treatment started 6-24 hours from TLKW * Ischemic core ≤ 50 cc 7. Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours). Exclusion Criteria: 1. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept). 2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration. 3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories 4. Cerebral vasculitis 5. History of severe allergy to contrast medium. 6. Known allergy to NeVa materials (nitinol, stainless steel) 7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis 8. Systemic infection 9. Significant mass effect with midline shift 10. Evidence of intracranial tumor (except small meningioma) 11. Inability to deploy NeVA device for at least one pass for any other reason 12. Life expectancy less than 6 months 13. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Abu Dhabi

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • Hospital Espanol de Mendoza

    RECRUITING

    Mendoza, Argentina

  • Niguarda Hospital

    RECRUITING

    Milan, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.