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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: 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 120 eligible subjects at up 20 sites will participate in the study.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Vascular Neurology of Southern California
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
  • Georgia
    • Marietta, Georgia, United States, 30060
      • WellStar System Inc
  • Indiana
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center Dept of Diagnostic Radiology & Nuclear Med.
  • Tennessee
    • Knoxville, Tennessee, United States, 37902
      • Fort Sanders Regional
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≤ 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. Imaging Inclusion Criteria:

   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 is able and willing to give informed consent prior to 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, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, 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 [≤ 3 cm])
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. Females you are pregnant or breastfeeding.
16. Active malignancy
17. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; NeVa Stent Retrievers	Device: NeVa Stent Retrievers; mechanical neurothrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vesalio

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Thrombus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: VS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes