NeVa ONE Registry Study

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562194
• Other study ID #: VS-003/D
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 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 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 600 subjects will be enrolled at up 30 sites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Device:
• NeVa Stent Retriever
mechanical neurothrombectomy

Locations

Country	Name	City	State
Argentina	Hospital Espanol de Mendoza	Mendoza
Italy	Niguarda Hospital	Milan
United Arab Emirates	Cleveland Clinic Abu Dhabi	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Vesalio

Countries where clinical trial is conducted

Argentina,  Italy,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Pass Success Rate	The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score = 2B & eTICI =2C	post-procedure day 0