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Completed

NCT Number: NCT03898960

Post Marketing Study to Evaluate the NIMBUS Device

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UKE Hamburg, Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NIMBUS Device

Device

NIMBUS Geometric Clot Extractor

Primary outcomes

  1. Percentage of Participants With Successful Revascularization With NIMBUS Device

    Time frame: Day 1

    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.

Secondary outcomes

  1. Percentage of Participants With Successful Procedural Revascularization

    Time frame: Day 1

    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.

  2. Percentage of Participants With Excellent Procedural Revascularization

    Time frame: Day 1

    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.

  3. Percentage of Participants With First Pass Revascularization Using NIMBUS Device

    Time frame: Day 1

    First Pass revascularization was defined as achieving an mTICI score of 2b or greater after the first use of NIMBUS device 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.

  4. Percentage of Participants With Embolization to a New Territory (ENT)

    Time frame: Day 1

    Percentage of participants with ENT was reported.

  5. Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)

    Time frame: Day 1

    Percentage of participants with sICH according to the HBC was reported. sICH was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item: greater than or equal to (>=) 4 points total National Institute of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; >=2 point in one NIHSS category. The rationale for this was to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention; absence of alternative explanation for deterioration.

  6. Number of Participants With All-Cause Mortality

    Time frame: Up to Day 90

    Number of participants with all-cause mortality at 90 days post-procedure on Day 0 was reported. All-cause mortality included all deaths of participants due to any cause.

  7. Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2

    Time frame: Up to Day 90

    Percentage of participants with mRS score of <=2 was reported. The mRS was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death.

Sponsors and collaborators

Lead sponsor

Neuravi Limited

Industry

Registry information

Official study title

Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions

Acronym: SPERO

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2019
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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