Clinical trial NCT02190552: Analysis of Revascularisation in Ischemic Stroke With EmboTrap
Official title: A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Keywords: Brain
Brain Clot
Brain Diseases
Brain Infarction
Cerebral Ischemia
Cerebrovascular Disorders
EmboTrap® Revascularization Device
EmboTrap
Ischemia
Ischemic
Ischemic Stroke
Mechanical Thrombectomy
Neurovascular Intervention
Revascularization
Stent Retriever
Stroke
Vascular Diseases
Lead sponsor: Neuravi Limited
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic stroke patients

Brief summary: A.R.I.S.E. is a post approval observational study using standard care. The purpose of this study is to collect information about the ability of the EmboTrap device to remove blood clots from the brain, and the associated performance characteristics and clinical outcomes. No formal hypothesis testing is needed as no comparisons are planned within the study. Instead, estimates of each population parameter of interest for all primary and secondary endpoints will be provided using appropriate confidence intervals.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Revascularisation Following the Use of the Neuravi Device.
timeFrame: Day 1
Secondary outcomes:
measure: Time to Revascularization
timeFrame: Day 1
measure: Mortality Post Procedure
timeFrame: 7 and 90(±14) days post procedure
measure: Serious Adverse Device Related Effects (SADE)
timeFrame: 24(-8/+12) hours Post Procedure
measure: Symptomatic ICH
timeFrame: 24(-8/+12) hours Post Procedure
measure: Clinical Outcome at 90 Days
timeFrame: 90(±14) days Post Procedure
measure: Rate of New Territory Embolization
timeFrame: 24(-8/+12) hours Post Procedure
measure: Evidence of Infarction
timeFrame: 24(-8/+12) hours Post Procedure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Dr. Tommy Andersson
role: PRINCIPAL_INVESTIGATOR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Prof. Dr. Heinrich Mattle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mattle HP, Scarrott C, Claffey M, Thornton J, Macho J, Riedel C, Soderman M, Bonafe A, Piotin M, Newell J, Andersson T; ARISE I Study Group. Analysis of revascularisation in ischaemic stroke with EmboTrap (ARISE I study) and meta-analysis of thrombectomy. Interv Neuroradiol. 2019 Jun;25(3):261-270. doi: 10.1177/1591019918817406. Epub 2018 Dec 18.