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

NCT04514562 | Unknown DMC FDA Device

• 1 other identifier: VS-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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

Keywords

Thrombus

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).

  During the procedure/surgery

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 ≤ 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 is able and willing to give informed consent prior to the intervention

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, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, 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 \[≤ 3 cm\])
• 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.
• Females you are pregnant or breastfeeding.

Sponsors & Collaborators

• Vesalio: lead

Study Sites (7)

Vascular Neurology of Southern California

Thousand Oaks, California, 91360, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

WellStar System Inc

Marietta, Georgia, 30060, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

University of Maryland Medical Center Dept of Diagnostic Radiology & Nuclear Med.

Baltimore, Maryland, 21201, United States

Location

Fort Sanders Regional

Knoxville, Tennessee, 37902, United States

Location

Texas Tech University Health

El Paso, Texas, 79905, United States

Location

Related Publications (1)

• Yoo AJ, Geyik S, Froehler MT, Maurer CJ, Kass-Hout T, Zaidat OO, Nogueira RG, Hanel RA, Pierot L, Spelle L, Lopes D, Hassan A, Sirvinskas A, Lin E, Ribo M, Blasco J, Taqi MA, Badruddin A, Siddiqui AH, Miller TR, Hussain SM, Haussen DC, Woodward K, Groden C, Consoli A, Chaudry MI, Ramsey C, Maud A, Bentley J, Bajrami A, Sahnoun M, Fiehler J, Gupta R. Primary results from the CLEAR study of a novel stent retriever with drop zone technology. J Neurointerv Surg. 2024 Nov 22;16(12):1220-1227. doi: 10.1136/jnis-2023-020960.

  PMID: 38050090 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

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: August 11, 2020
• First Posted: August 17, 2020
• Study Start: April 3, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (7)