Cerebral StrokeSPERONCT03898960
Post Marketing Study to Evaluate the NIMBUS Device
An observational study of Cerebral Stroke, run by Neuravi Limited at 2 sites in 2 countries.
Trial summary
A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- NIMBUS Device
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Oct 2019to 8 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions
A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
Read the 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.
- Conditions
- Cerebral Stroke
- Being tested
- NIMBUS Device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIMBUS DeviceDevice
NIMBUS Geometric Clot Extractor
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Thrombectomy | NIMBUS Device Receives: Device: NIMBUS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
Percentage of Participants With Successful Procedural Revascularization
Successful procedural revascularization was defined as achieving an mTICI score of 2b or greater at the end of procedure as determined by an Independent Core Laboratory. The 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% 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.
Measured: Day 1
Percentage of Participants With Excellent Procedural Revascularization
Excellent procedural revascularization was defined as achieving an mTICI score of 2c or greater at the end of procedure as determined by an Independent Core Laboratory. The 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% 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.
Measured: Day 1
Percentage of Participants With First Pass Revascularization Using NIMBUS Device
First Pass revascularization was defined as achieving an mTICI score of 2b or greater after the first use of NIMBUS device as determined by an Independent Core Laboratory. The 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% 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.
Measured: Day 1
Percentage of Participants With Embolization to a New Territory (ENT)
Percentage of participants with ENT was reported.
Measured: Day 1
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)
Percentage of participants with sICH according to the HBC was reported. sICH was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item: greater than or equal to (>=) 4 points total National Institute of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; >=2 point in one NIHSS category. The rationale for this was to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention; absence of alternative explanation for deterioration.
Measured: Day 1
Number of Participants With All-Cause Mortality
Number of participants with all-cause mortality at 90 days post-procedure on Day 0 was reported. All-cause mortality included all deaths of participants due to any cause.
Measured: Up to Day 90
Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2
Percentage of participants with mRS score of <=2 was reported. The mRS was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start30 Oct 2019
- Primary completion15 Feb 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuravi Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- René van den Berg, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898960
- Sponsor's protocol ID
- CNV_2018_01
- Acronym
- SPERO
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2019
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Publications
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.
PubMed 41494867
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions
- ClinicalTrials.gov ID
- NCT03898960
- Acronym / sponsor ID
- SPERO / CNV_2018_01
- Conditions
- Cerebral Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Neuravi LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 27 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Thrombectomy | – | Device: NIMBUS DeviceNIMBUS Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIMBUS DeviceNIMBUS Geometric Clot Extractor | Device | Mechanical Thrombectomy |
Primary outcome
Percentage of Participants With Successful Revascularization With NIMBUS Device
Time frame: Day 1
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.
7 secondary outcomes
Percentage of Participants With Successful Procedural Revascularization
Time frame: Day 1
Percentage of Participants With Excellent Procedural Revascularization
Time frame: Day 1
Percentage of Participants With First Pass Revascularization Using NIMBUS Device
Time frame: Day 1
Percentage of Participants With Embolization to a New Territory (ENT)
Time frame: Day 1
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)
Time frame: Day 1
Number of Participants With All-Cause Mortality
Time frame: Up to Day 90
Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2
Time frame: Up to Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41494867van 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.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René van den Berg, MD, PhD principal investigator
Amsterdam UMC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Stroke, run by Neuravi Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Successful Revascularization With NIMBUS Device (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.