Clinical trial NCT03898960: Post Marketing Study to Evaluate the NIMBUS Device
Official title: Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Lead sponsor: Neuravi Limited
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.

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

Detailed description: 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.

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).

Primary outcomes:
measure: Percentage of Participants With Successful Revascularization With NIMBUS Device
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants With Successful Procedural Revascularization
timeFrame: Day 1
measure: Percentage of Participants With Excellent Procedural Revascularization
timeFrame: Day 1
measure: Percentage of Participants With First Pass Revascularization Using NIMBUS Device
timeFrame: Day 1
measure: Percentage of Participants With Embolization to a New Territory (ENT)
timeFrame: Day 1
measure: Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)
timeFrame: Day 1
measure: Number of Participants With All-Cause Mortality
timeFrame: Up to Day 90
measure: Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2
timeFrame: Up to Day 90
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Amsterdam UMC
name: René van den Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: