Clinical trial NCT04514562: The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Thrombus
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Recanalization rate of the occluded target vessel
timeFrame: During the procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Vascular Neurology of Southern California
state: California
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Marietta
country: United States
facility: WellStar System Inc
state: Georgia
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center Dept of Diagnostic Radiology & Nuclear Med.
state: Maryland
city: Knoxville
country: United States
facility: Fort Sanders Regional
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University Health
state: Texas
Study officials:
References: