N/A
N=54
Post Marketing Study to Evaluate the NIMBUS Device
Cerebral Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03898960 ↗Enrolled (actual)
54
Serious AEs
38.9%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Participants With Successful Revascularization With NIMBUS Device — 68.6 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NIMBUS Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neuravi Limited
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-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 | — |
Summary
A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
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).
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.