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Trial record 5 of 211 for:    (ARISE)

Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Neuravi Limited
Sponsor:
Information provided by (Responsible Party):
Neuravi Limited
ClinicalTrials.gov Identifier:
NCT02190552
First received: July 10, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Ischemic Stroke
Device: EmboTrap® Revascularization Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Neuravi Limited:

Primary Outcome Measures:
  • Revascularisation as measured by modified Thrombolysis in Cerebrovascular Infarction (mTICI with 2c) score of at least 2b following the use of the Neuravi device. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Revascularization [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Defined as time from groin puncture to visualization of final angiographic result.

  • Mortality post procedure [ Time Frame: 7 and 90(±14) days post procedure ] [ Designated as safety issue: No ]
    All procedure related mortality (i.e. directly traceable to a procedure related SAE).

  • Serious Adverse Device related effects (SADE) [ Time Frame: 24(-8/+12) hours Post Procedure ] [ Designated as safety issue: No ]
    SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.

  • Symptomatic ICH [ Time Frame: 24(-8/+12) hours Post Procedure ] [ Designated as safety issue: No ]
    Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.

  • Clinical outcome at 90 days [ Time Frame: 90(±14) days Post Procedure ] [ Designated as safety issue: No ]
    A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.

  • Rate of New Territory Embolization [ Time Frame: 24(-8/+12) hours Post Procedure ] [ Designated as safety issue: No ]
    Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.

  • Evidence of Infarction [ Time Frame: 24(-8/+12) hours Post Procedure ] [ Designated as safety issue: No ]
    Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.


Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
Device: EmboTrap® Revascularization Device
Other Name: EmboTrap

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ischemic stroke patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190552

Contacts
Contact: Mairsíl Claffey +35391394121 mclaffey@neuravi.com

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
France
Hôpital Gui de Chauliac Not yet recruiting
Montpellier, France
Hôpital Rothschild Not yet recruiting
Paris, France
Germany
Klinikum Augsburg Not yet recruiting
Augsburg, Germany
Universitatsklinikum Köln Not yet recruiting
Cologne, Germany
Universitätsklinikum Kiel Not yet recruiting
Kiel, Germany
Ireland
Beaumont Hospital Not yet recruiting
Dublin, Ireland
Spain
Hospital Clinico de Barcelona Not yet recruiting
Barcelona, Spain
Hospital Virgen de la Arreixaca Not yet recruiting
Murcia, Spain
Sweden
Karolinska Institutet Not yet recruiting
Solna, Sweden, 17176
Switzerland
Universität Bern Not yet recruiting
Bern, Switzerland
Hopitaux Universitaires de Geneve Not yet recruiting
Genéve, Switzerland
Sponsors and Collaborators
Neuravi Limited
Investigators
Principal Investigator: Dr. Tommy Andersson Karolinska Institutet
Principal Investigator: Prof. Dr. Heinrich Mattle University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Neuravi Limited
ClinicalTrials.gov Identifier: NCT02190552     History of Changes
Other Study ID Numbers: CIP001
Study First Received: July 10, 2014
Last Updated: July 21, 2014
Health Authority: Sweden: Medical Products Agency
Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Health and Medicines Authority

Keywords provided by Neuravi Limited:
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

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014