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

• ClinicalTrials.gov Identifier: NCT04514562
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2020
• Last Update Posted: January 17, 2023
• Sponsor: Vesalio
• Information provided by (Responsible Party): Vesalio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Device: NeVa Stent Retrievers	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 3, 2021
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Intervention; NeVa Stent Retrievers	Device: NeVa Stent Retrievers; mechanical neurothrombectomy

Outcome Measures

Primary Outcome Measures :

1. Recanalization rate of the occluded target vessel [ Time Frame: During the procedure/surgery ]
   Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s).

Eligibility Criteria

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

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 ≤ 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.

Contacts and Locations

Locations

United States, California

Vascular Neurology of Southern California

Thousand Oaks, California, United States, 91360

United States, Florida

Baptist Health Research Institute

Jacksonville, Florida, United States, 32207

United States, Georgia

WellStar System Inc

Marietta, Georgia, United States, 30060

United States, Indiana

Community Hospital

Munster, Indiana, United States, 46321

United States, Maryland

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

Baltimore, Maryland, United States, 21201

United States, Tennessee

Fort Sanders Regional

Knoxville, Tennessee, United States, 37902

United States, Texas

Texas Tech University Health

El Paso, Texas, United States, 79905

Sponsors and Collaborators

Vesalio

More Information

• Responsible Party: Vesalio
• ClinicalTrials.gov Identifier: NCT04514562
• Other Study ID Numbers: VS-001
• First Posted: August 17, 2020
• Last Update Posted: January 17, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Vesalio:

Thrombus

Additional relevant MeSH terms:

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