- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898960
Post Marketing Study to Evaluate the NIMBUS Device (SPERO)
February 15, 2023 updated by: Neuravi Limited
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.
Study Overview
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
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mechanical Thrombectomy
NIMBUS Device
|
NIMBUS Geometric Clot Extractor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Successful Procedural Revascularization
Time Frame: Day 1
|
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.
|
Day 1
|
Percentage of Participants With Excellent Procedural Revascularization
Time Frame: 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.
|
Day 1
|
Percentage of Participants With First Pass Revascularization Using NIMBUS Device
Time Frame: 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.
|
Day 1
|
Percentage of Participants With Embolization to a New Territory (ENT)
Time Frame: Day 1
|
Percentage of participants with ENT was reported.
|
Day 1
|
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC)
Time Frame: 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.
|
Day 1
|
Number of Participants With All-Cause Mortality
Time Frame: 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.
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: René van den Berg, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2019
Primary Completion (Actual)
February 15, 2022
Study Completion (Actual)
April 8, 2022
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
March 29, 2019
First Posted (Actual)
April 2, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNV_2018_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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