Trial Outcomes & Findings for Post Marketing Study to Evaluate the NIMBUS Device (NCT NCT03898960)

Last Updated: 2025-04-25

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

54 participants

Primary outcome timeframe

Day 1

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	54
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	10

Baseline Characteristics

Post Marketing Study to Evaluate the NIMBUS Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 Participants 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.
Age, Continuous	71.9 Years STANDARD_DEVIATION 14.09 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=51 Participants 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.
Percentage of Participants With Successful Revascularization With NIMBUS Device	68.6 Percentage of participants Interval 54.1 to 80.9

SECONDARY outcome

Timeframe: Day 1

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=53 Participants 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.
Percentage of Participants With Successful Procedural Revascularization	79.2 Percentage of participants Interval 65.9 to 89.2

SECONDARY outcome

Timeframe: Day 1

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=53 Participants 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.
Percentage of Participants With Excellent Procedural Revascularization	37.7 Percentage of participants Interval 24.8 to 52.1

SECONDARY outcome

Timeframe: Day 1

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=51 Participants 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.
Percentage of Participants With First Pass Revascularization Using NIMBUS Device	52.9 Percentage of participants Interval 38.5 to 67.1

SECONDARY outcome

Timeframe: Day 1

Percentage of participants with ENT was reported.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 Participants 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.
Percentage of Participants With Embolization to a New Territory (ENT)	0 Percentage of participants Interval 0.0 to 6.6

SECONDARY outcome

Timeframe: Day 1

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 Participants 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.
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)	3.7 Percentage of participants Interval 0.5 to 12.7

SECONDARY outcome

Timeframe: Up to Day 90

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 Participants 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.
Number of Participants With All-Cause Mortality	10 Participants

SECONDARY outcome

Timeframe: Up to Day 90

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Mechanical Thrombectomy: NIMBUS Device n=15 Participants 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.
Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2	46.7 Percentage of participants Interval 21.3 to 73.4

Adverse Events

Mechanical Thrombectomy: NIMBUS Device

Serious events: 21 serious events

Other events: 6 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 participants at risk 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.
Nervous system disorders Stroke in evolution	7.4% 4/54 • Number of events 4 • 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).
Nervous system disorders Hemorrhagic transformation stroke	5.6% 3/54 • Number of events 3 • 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).
Nervous system disorders Brain oedema	1.9% 1/54 • Number of events 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).
Nervous system disorders Cerebral hemorrhage	1.9% 1/54 • Number of events 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).
Nervous system disorders Ischemic stroke	1.9% 1/54 • Number of events 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).
Nervous system disorders Subarachnoid hemorrhage	1.9% 1/54 • Number of events 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).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	14.8% 8/54 • Number of events 8 • 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).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 2/54 • Number of events 2 • 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).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.9% 1/54 • Number of events 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).
Infections and infestations Bacteriuria	1.9% 1/54 • Number of events 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).
Infections and infestations Bronchitis hemophilus	1.9% 1/54 • Number of events 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).
Infections and infestations Endocarditis	1.9% 1/54 • Number of events 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.9% 1/54 • Number of events 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).
Vascular disorders Deep vein thrombosis	1.9% 1/54 • Number of events 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).

Other adverse events

Other adverse events
Measure	Mechanical Thrombectomy: NIMBUS Device n=54 participants at risk 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.
Nervous system disorders Stroke in evolution	1.9% 1/54 • Number of events 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).
Nervous system disorders Hemianopia	1.9% 1/54 • Number of events 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).
Nervous system disorders Partial seizures	1.9% 1/54 • Number of events 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).
Nervous system disorders Presyncope	1.9% 1/54 • Number of events 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).
Ear and labyrinth disorders Vertigo positional	1.9% 1/54 • Number of events 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).
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	1.9% 1/54 • Number of events 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).

Additional Information

Senior Director Clinical Research

CERENOVUS

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER