Post Marketing Study to Evaluate the NIMBUS Device

NCT03898960 | Completed Results

• 1 other identifier: CNV_2018_01
• Study Type: observational
• Target: 54
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Revascularization With NIMBUS Device

  Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \[90-99%\] of downstream territory; 3=Complete and 100% reperfusion.

  Day 1

Secondary Outcomes (7)

• Percentage of Participants With Successful Procedural Revascularization

  Day 1

• Percentage of Participants With Excellent Procedural Revascularization

  Day 1

• Percentage of Participants With First Pass Revascularization Using NIMBUS Device

  Day 1

• Percentage of Participants With Embolization to a New Territory (ENT)

  Day 1

• Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)

  Day 1

Study Arms (1)

Mechanical Thrombectomy

NIMBUS Device

Device: NIMBUS Device

Interventions

NIMBUS Device DEVICE

NIMBUS Geometric Clot Extractor

Mechanical Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neuravi Limited: lead

Study Sites (2)

UKE Hamburg

Hamburg, Germany

Location

Karolinska Institute

Stockholm, Sweden

Location

Related Publications (1)

• van den Berg R, Ribo M, Arnberg Sandor F, Estrade L, Thornton J, Tomasello A, Gontu V, Hernandez D, Karam A, Bricout N, Buhk JH, Clarencon F, Desal H, Januel AC, Nouri N, Wiesmann M, Doyle K, Liebeskind DS, McManus C, Mirza M, Andersson T, Brouwer P. Post-marketing study of patients to evaluate NIMBUS revascularization effectiveness with challenging occlusions (SPERO): study results. J Neurointerv Surg. 2026 Jan 6:jnis-2025-023811. doi: 10.1136/jnis-2025-023811. Online ahead of print.

  PMID: 41494867 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Thrombus/Clot

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: CERENOVUS

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• René van den Berg, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: October 30, 2019
• Primary Completion: February 15, 2022
• Study Completion: April 8, 2022
• Last Updated: April 25, 2025
• Results First Posted: November 27, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); SE (1)