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A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Thrombectomy | NIMBUS Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIMBUS Device | Device | NIMBUS Geometric Clot Extractor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.
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| Name | Affiliation | Role |
|---|---|---|
| René van den Berg, MD, PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKE Hamburg | Hamburg | Germany | ||||
| Karolinska Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41494867 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Mechanical Thrombectomy: NIMBUS Device | Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mechanical Thrombectomy: NIMBUS Device | Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified intent-to-treat (mITT) analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
Up to Day 90
Safety set included all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mechanical Thrombectomy: NIMBUS Device | Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke in evolution | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke in evolution | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | CERENOVUS | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2020 | Feb 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2022 | Feb 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Thrombus/Clot
| 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. | 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. | Day 1 |
| Percentage of Participants With Embolization to a New Territory (ENT) | Percentage of participants with ENT was reported. | 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. | 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. | 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. | Up to Day 90 |
| Stockholm |
| Sweden |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Mechanical Thrombectomy: NIMBUS Device | Participants with acute ischemic stroke who had post one or two unsuccessful passes of another mechanical thrombectomy therapy and did not achieve modified thrombolysis in cerebrovascular infarction (mTICI) 2b or better, were treated with NIMBUS device. |
|
|
| Secondary | 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. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
|
| Secondary | 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. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
|
| Secondary | 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. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
|
| Secondary | Percentage of Participants With Embolization to a New Territory (ENT) | Percentage of participants with ENT was reported. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
|
| Secondary | 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. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
|
| Secondary | 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. | The mITT analysis set consisted of all participants who were enrolled into the study, and who had attempted at least one pass with the NIMBUS device (which included deployment and retrieval with the NIMBUS device). | Posted | Count of Participants | Participants | Up to Day 90 |
|
|
|
| Secondary | 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. | The mRS analysis set consisted of all mITT participants who met study criteria as MRI criterion: volume of diffusion restriction visually assessed <=50 milliliter(mL), computed tomography(CT) criterion: ASPECTS 6 to 10 on baseline CT, computed tomography angiography(CTA)-source images or volume of significantly lowered cerebral blood volume(CBV) <=50 mL; NIHSS >=8 and less than (<)30; participants treated within 6 hours of onset of stroke symptoms (start of treatment defined as groin puncture). | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 90 |
|
|
|
| 10 |
| 54 |
| 21 |
| 54 |
| 6 |
| 54 |
| Hemorrhagic transformation stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis hemophilus | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Hemianopia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Partial seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |