Post Marketing Study to Evaluate the NIMBUS Device

Neuravi Limited54 enrolled

Overview

A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

The objective of this study is to assess the efficacy of the NIMBUS Device. The study will also report on clot characteristics and clinical outcomes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cerebral Stroke

Interventions

NIMBUS DeviceDEVICE

NIMBUS Geometric Clot Extractor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 * The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form. * Patient has had one or two passes of another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel. * mRS 0-1 prior to this stroke. * NIMBUS is used on the second or third overall pass to attempt revascularization. Exclusion Criteria: * Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. * Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication). * All patients with severe hypertension on presentation (SBP \> 220 mmHg and/or DBP \> 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP \>185 mmHg and/ or DBP \>110 mmHg). * Known cerebral vasculitis. * Known cancer with life expectancy less than 12 months. * Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion. * Intracranial stenosis that prevents access to the site of occlusion. * Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. * Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma). * Evidence of dissection in the extra or intracranial cerebral arteries. * Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Locations (2)

UKE Hamburg

Hamburg, Germany

Karolinska Institute

Stockholm, Sweden

Outcomes

Primary Outcomes

Percentage of Participants With Successful Revascularization With NIMBUS Device

Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \[90-99%\] of downstream territory; 3=Complete and 100% reperfusion.

Time frame: Day 1

Secondary Outcomes

Percentage of Participants With Successful Procedural Revascularization

Successful procedural revascularization was defined as achieving an mTICI score of 2b or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in \[67-89%\] of downstream territory); 2c=Reperfusion in \[90-99%\] of downstream territory; 3=Complete and 100% reperfusion.

Time frame: Day 1

Percentage of Participants With Excellent Procedural Revascularization

Excellent procedural revascularization was defined as achieving an mTICI score of 2c or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in \[67-89%\] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion.

Data from ClinicalTrials.gov

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