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

NCT03927001 | Unknown DMC FDA Device

• 1 other identifier: VS-006 / G
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Recanalization rate of the occluded target vessel

  Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).

  post-procedure day 0

Study Arms (1)

Intervention

OTHER

NeVa Stent Retrievers

Device: NeVa Stent Retrievers

Interventions

NeVa Stent Retrievers DEVICE

mechanical neurothrombectomy

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
• Subject has failed IV t-PA therapy
• Subject is contraindicated for IV t-PA administration
• IV-tPA given within 3 hours of symptom onset
• Age ≥18 and less than equal to 85
• NIHSS score ≥ 8 and ≤ 25
• Prestroke mRS score of ≤ 1
• 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.
• 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
• Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or
• CT Perfusion core ≤50 cc, or
• MRI DWI core ≤50 cc
• 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.

You may not qualify if:

• 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).
• Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Cerebral vasculitis
• History of severe allergy to contrast medium.
• Known allergy to NeVa materials (nitinol, stainless steel);
• Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
• Systemic infection
• Significant mass effect with midline shift
• Evidence of intracranial tumor (except small meningioma \[≤ 3cm\])
• Any CT or MRI evidence of acute hemorrhage products on presentation
• Inability to deploy NeVA device for at least one pass for any other reason
• Life expectancy less than 6 months
• 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.
• Active malignancy

Sponsors & Collaborators

• Vesalio: lead

Study Sites (1)

Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 25, 2019
• Study Start: April 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

ES (1)