The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Device: NeVa Stent Retriever

• Registration Number: NCT03926988
• Lead Sponsor: Vesalio

Brief Summary

A prospective, open label, 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Detailed Description

This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 400 subjects at up 20 sites will participate in the study.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Only subjects already treated with the NeVa devices can be considered for enrollment.

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:

   1.1. Subject has failed IV t-PA therapy

   1.2. Subject is contraindicated for IV t-PA administration

2. Age ≥18

3. NIHSS score ≥ 6

4. Pre-stroke mRS score of ≤ 1

5. 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.

6. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well [TLKW])

7. Imaging Inclusion Criteria:

   7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 if treatment started 0-6 hours from TLKW ASPECTS 8-10 if treatment started 6-24 hours from TLKW

   7.2. CT Perfusion core ≤50 cc

   7.3. MRI DWI core ≤50 cc

8. Subject or legal representative is able and willing to give informed consent within 48 hours after the intervention.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	NeVa Stent Retriever	NeVa Stent Retriever

Primary Outcome Measures

Name	Time	Method
Recanalization rate of occluded target vessel	post-procedure day 0	Recanalization rate of occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).

Trial Locations

Locations (1)

Vall d'Hebron; 🇪🇸 Barcelona, Spain