Post Marketing Study to Evaluate the NIMBUS Device

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-30

Study Completion Date

2022-04-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cerebral Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanical Thrombectomy

NIMBUS Device

Intervention Type DEVICE

NIMBUS Geometric Clot Extractor

Interventions

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NIMBUS Device

NIMBUS Geometric Clot Extractor

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No