Post Marketing Study to Evaluate the NIMBUS Device (SPERO)

Neuravi

Status

Completed

Conditions

Cerebral Stroke

Treatments

Device: NIMBUS Device

Study type

Observational

Funder types

Industry

Identifiers

CNV_2018_01

Details and patient eligibility

About

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

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).