FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial

NCT04072367 | Withdrawn DMC FDA Device

• 1 other identifier: VS-007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Reperfusion rate

  The primary study endpoint is the reperfusion rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following one single pass using the assigned stent retriever device(s)

  post-procedure day 0

Secondary Outcomes (1)

• Stent retriever comparison

  Day 90

Study Arms (2)

Active Treatment Group

OTHER

NeVa Stent Retrievers

Device: NeVa Stent Retrievers

Control Device

OTHER

Solitare Stent Retrievers

Device: Solitaire Stent Retrievers

Interventions

NeVa Stent Retrievers DEVICE

thrombus removal

Active Treatment Group

Solitaire Stent Retrievers DEVICE

thrombus removal

Control Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• A new focal disabling neurologic deficit consistent with acute cerebral ischemia
• NIHSS score ≥ 6;
• Prestroke mRS score of ≤ 2;
• Angiographic confirmation by DSA of an occlusion (eTICI 0-1) of the intracranial ICA, MCA-M1, MCA-M2, basilar artery, or intracranial vertebral artery with or without tandem involvement of the cervical ICA or cervical vertebral artery;
• Imaging Criteria:
• Strokes in the Anterior Circulation:
• Non-Contrast CT (NCCT): ASPECTS 6 to 10 on baseline CT, or
• CT perfusion (with Automated Volume Calculation): core infarct volume ≤ 70cc and Mismatch Ratio ≥ 1.5
• CT perfusion (without Automated Volume Calculation): ASPECTS 6 to 10 on the CBV maps with Visualized MTT or TMax - CBV Mismatch greater than 50%, or
• Brain MRI: ASPECTS 6 to 10 (and \<70cc if Automated Volume Calculation is available) on baseline diffusion-weighted sequence (DWI).
• Strokes in the Posterior Circulation: pc-ASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI.
• Subjects for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA within 4.5 hours of stroke onset (onset time is defined as the last time when the subject was witnessed to be at baseline), with verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight
• Arterial puncture within 12 hours of symptom onset (or time last seen well - TLSW), thrombectomy procedure able to be completed within 2 hours from procedure start (arterial puncture).
• Subject or legal representative is able and willing to give informed consent.

You may not qualify if:

• Rapid neurological improvement prior to groin puncture suggestive of resolution of stroke
• Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
• Note: Subjects with a questionable seizure at onset of stroke should not be excluded if DSA confirms the presence of intracranial ICA and/or M1 occlusion, and accurate NIHSS can be obtained.
• 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).
• Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Cerebral vasculitis.
• History of severe allergy to contrast medium.
• Known allergy to stent retriever materials (nitinol, stainless steel);
• Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
• Active infection.
• Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma \[≤ 3 cm\]).
• CT or MRI evidence of recent/fresh hemorrhage on presentation.
• CTA, MRA, or DSA evidence of flow limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy).
• Evidence of dissection in the intracranial cerebral arteries;

Sponsors & Collaborators

• Vesalio: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Raul Gomes Nogueira, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 27, 2023

Record last verified: 2020-05