Registry for assessing thrombus removal in acute ischemic stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, open label registry aims to evaluate the safety, performance, and efficacy of the NeVa stent retriever in treating large vessel occlusion strokes. Up to 600 subjects will be enrolled across 30 sites, focusing on patients who have already undergone treatment with the NeVa thrombectomy devices. The study will assess outcomes based on various imaging criteria and clinical assessments, including the NIHSS score and pre-stroke mRS score.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Espanol de Mendoza
  Mendoza, Argentina Recruiting
• Niguarda Hospital
  Milan, Italy Recruiting
• Cleveland Clinic Abu Dhabi
  Abu Dhabi, United Arab Emirates Recruiting

Study contacts

• Study coordinator: Antoine Cuijpers
• Email: acuijpers@vesalio.com
• Phone: +31 6 51 55 99 37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.