Mode
Text Size
Log in / Sign up
N/A Completed N=54

Post Marketing Study to Evaluate the NIMBUS Device

Cerebral Stroke
Source: ClinicalTrials.gov NCT03898960 ↗
Enrolled (actual)
54
Serious AEs
38.9%
Results posted
Nov 2023
Primary outcomePrimary: Percentage of Participants With Successful Revascularization With NIMBUS Device — 68.6 Percentage of participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Successful Revascularization With NIMBUS Device
68.6 —
SECONDARY
Percentage of Participants With Successful Procedural Revascularization
79.2 —
SECONDARY
Percentage of Participants With Excellent Procedural Revascularization
37.7 —
SECONDARY
Percentage of Participants With First Pass Revascularization Using NIMBUS Device
52.9 —
SECONDARY
Percentage of Participants With Embolization to a New Territory (ENT)
— —
SECONDARY
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)
3.7 —
SECONDARY
Number of Participants With All-Cause Mortality
10 —
SECONDARY
Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2
46.7 —

Eligibility Criteria

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03898960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search