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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02190552 |
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Date of registration:
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10/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Analysis of Revascularisation in Ischemic Stroke With EmboTrap
ARISE |
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Scientific title:
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A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02190552 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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France
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Germany
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Ireland
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Spain
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Sweden
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Switzerland
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Contacts
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Name:
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Prof. Dr. Heinrich Mattle |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Inselspital, Berne |
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Name:
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Dr. Tommy Andersson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The patient or the patient's legally authorized representative has signed and dated an
Informed Consent Form.
- Aged between 18 years and 80 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score =8 and =25.
- Pre-ictal mRS score of 0 or 1.
- Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1
or M2, MCA, or BA with TICI flow of 0-1.
- Confirmation by the interventionalist, after screening CT or MRI, that the treatment
site can be accessed with the Neuravi device.
- The interventionalist estimates that at least one deployment of the Neuravi device can
be completed within 5 hours from the onset of symptoms, or if time of onset of
symptoms is unknown or > 5 hours, patients can be included using imaging with the
following criteria:
1. MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction =30 mL and
mismatch between perfusion reduction and diffusion restriction present.
2. CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of
significantly lowered CBV =30 mL and mismatch between perfusion reduction and low
CBV present.
Exclusion Criteria:
- Life expectancy of less than 6 months.
- Females who are pregnant or lactating.
- History of severe allergy to contrast medium.
- Has suffered a stroke in the past three months.
- The patient presents with an NIHSS score <8 or >25 or is physician assessed as being
in a clinically relevant uninterrupted coma.
- Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0.
- Platelet count < 50,000.
- Glucose < 50 mg/dL.
- Heparin use in previous 24 hours with PTT or ACT > 2X normal.
- Any known hemorrhagic or coagulation deficiency.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh
hemorrhage on presentation.
- For basilar artery occlusion, extended early ischemic changes as confirmed by
pc-ASPECTS = 7 on baseline CT or CTA-source images, or extensive DWI lesions in the
midbrain or pons regions on pre-treatment MRI.
- Baseline CT or MRI showing mass effect or intracranial tumor (except small
meningioma).
- Excessive arterial tortuosity that precludes the study device from reaching the target
vessel.
- A proximal stenosis or complete occlusion that cannot, as judged by the responsible
interventionalist, be treated safely or which prevents access to the occluded vessel
with the Neuravi device.
- Evidence of active infection.
- Known cancer with metastases
- Current use of cocaine or other vasoactive substance.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ischemic Stroke
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Intervention(s)
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Device: EmboTrap® Revascularization Device
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Primary Outcome(s)
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Proportion of Revascularisation Following the Use of the Neuravi Device.
[Time Frame: Day 1]
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Secondary Outcome(s)
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Clinical Outcome at 90 Days
[Time Frame: 90(±14) days Post Procedure]
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Evidence of Infarction
[Time Frame: 24(-8/+12) hours Post Procedure]
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Mortality Post Procedure
[Time Frame: 7 and 90(±14) days post procedure]
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Rate of New Territory Embolization
[Time Frame: 24(-8/+12) hours Post Procedure]
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Symptomatic ICH
[Time Frame: 24(-8/+12) hours Post Procedure]
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Serious Adverse Device Related Effects (SADE)
[Time Frame: 24(-8/+12) hours Post Procedure]
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Time to Revascularization
[Time Frame: Day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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