Registry for assessing thrombus removal in acute ischemic stroke patients

NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry

This study is testing how well the NeVa stent retriever works for removing blood clots in patients who have had a stroke caused by blocked large blood vessels.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vesalio (industry)
• Locations: 3 sites (Mendoza and 2 other locations)
• Trial ID: NCT04562194 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed large vessel occlusion and who have been treated with the NeVa thrombectomy devices.

Not a fit: Patients who have not been treated with the NeVa thrombectomy devices or those with severe pre-existing disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from acute ischemic stroke by enhancing thrombus removal techniques.

How similar studies have performed: Other studies have shown success with similar thrombus removal techniques, indicating a promising approach in this area.

Eligibility criteria

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 this trial is running

Mendoza and 2 other locations

• 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

Conditions: Acute Ischemic Stroke, Thrombus, stroke