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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926988
• Other study ID #: VS-005 / D
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 2024

Study information

• Verified date: January 2023
• Source: Vesalio
• Contact: Antoine Cuijpers
• Phone: +31 6 51 55 99 37
• Email: acuijpers[@]vesalio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• NeVa Stent Retriever
mechanical neurothrombectomy

Locations

Country	Name	City	State
Spain	Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Vesalio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization rate of occluded target vessel	Recanalization rate of occluded target vessel (defined by an eTICI score = 2b) following three or less passes using the NeVa device(s).	post-procedure day 0