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NCT03898960 | COMPLETED | Cerebral Stroke

Post Marketing Study to Evaluate the NIMBUS Device
Sponsor:

Neuravi Limited

Brief Summary:

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

Condition or disease

Cerebral Stroke

Intervention/treatment

NIMBUS Device

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 54 participants
Official Title : Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions
Actual Study Start Date : 2019-10-30
Estimated Primary Completion Date : 2022-02-15
Estimated Study Completion Date : 2022-04-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Post Marketing Study to Evaluate the NIMBUS Device

Location Details

NCT03898960

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany,

Week hamburg

Hamburg, Germany,

Not yet recruiting

Sweden,

Karolinska Institute

Stockholm, Sweden,