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

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04514562
• Other study ID #: VS-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 3, 2021
• Est. completion date: August 2023

Study information

• Verified date: January 2023
• Source: Vesalio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• NeVa Stent Retrievers
mechanical neurothrombectomy

Locations

Country	Name	City	State
United States	University of Maryland Medical Center Dept of Diagnostic Radiology & Nuclear Med.	Baltimore	Maryland
United States	Texas Tech University Health	El Paso	Texas
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	Fort Sanders Regional	Knoxville	Tennessee
United States	WellStar System Inc	Marietta	Georgia
United States	Community Hospital	Munster	Indiana
United States	Vascular Neurology of Southern California	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Vesalio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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