- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03927001
Recruitment Status Recruiting
First Posted April 25, 2019
Last update posted August 17, 2020
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.
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 150 subjects at up 20 sites will participate in the study.
NeVa Stent Retrievers
Device: NeVa Stent Retrievers
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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 less than equal to 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 ,
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
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, significant cardiac arrhythmia, 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 [≤ 3cm])
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. Active malignancy
16. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to
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