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

NCT ID: NCT03927001

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2024-08-31

Brief Summary

A prospective, open label, single-arm 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, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 150 subjects at up 20 sites will participate in the study.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

NeVa Stent Retrievers

Group Type: OTHER

NeVa Stent Retrievers

Intervention Type: DEVICE

mechanical neurothrombectomy

Interventions

NeVa Stent Retrievers

mechanical neurothrombectomy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

1.3. IV-tPA given within 3 hours of symptom onset

2. Age ≥18 and less than equal to 85

3. NIHSS score ≥ 8 and ≤ 25

4. Prestroke 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 8 hours from symptom onset (defined as time last known well [TLKW]) and at least one NeVa pass occurring within 8 hours

7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or

7.2. CT Perfusion core ≤50 cc, or

7.3. MRI DWI core ≤50 cc

8. Subject or (legal) representative or independent physician (if approved by site's regional ethics committee, see site's informed consent form) is able and willing to give informed consent prior to the interventions.

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 [≤ 3cm])

11. Any CT or MRI evidence of acute hemorrhage products on presentation

12. Inability to deploy NeVA device for at least one pass for any other reason

13. Life expectancy less than 6 months

14. 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.

15. Active malignancy

16. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vesalio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vall d'Hebron

Barcelona, , Spain

Countries

Spain

Other Identifiers

VS-006 / G

Identifier Type: -

Identifier Source: org_study_id