Analysis of Revascularisation in Ischemic Stroke With EmboTrap

NCT02190552 | Terminated Results DMC

• 1 other identifier: CIP001
• Study Type: observational
• Target: 40
• Locations: 5 countries
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Revascularisation Following the Use of the Neuravi Device.

  Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of \<50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion

  Day 1

Secondary Outcomes (7)

• Time to Revascularization

  Day 1

• Mortality Post Procedure

  7 and 90(±14) days post procedure

• Serious Adverse Device Related Effects (SADE)

  24(-8/+12) hours Post Procedure

• Symptomatic ICH

  24(-8/+12) hours Post Procedure

• Clinical Outcome at 90 Days

  90(±14) days Post Procedure

Study Arms (1)

EmboTrap® Revascularization Device

The EmboTrap® Revascularization Device is the investigational device

Device: EmboTrap® Revascularization Device

Interventions

EmboTrap® Revascularization Device DEVICE

Also known as: EmboTrap

EmboTrap® Revascularization Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ischemic stroke patients

You may qualify if:

• 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:
• MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuravi Limited: lead

Study Sites (5)

Aarhus University Hospital

Aarhus, Denmark

Location

Universitätsklinikum Kiel

Kiel, Germany

Location

Beaumont Hospital

Dublin, Ireland

Location

Hospital Clinico de Barcelona

Barcelona, Spain

Location

Karolinska Institutet

Solna, 17176, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30563388 DERIVED

Related Links

• Company website

MeSH Terms

Conditions

Ischemic Stroke; Brain Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Ischemia; Stroke; Vascular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Mairsil Claffey
• Organization: Neuravi Limited

mclaffey@neuravi.com

0035391394123

Study Officials

• Dr. Tommy Andersson

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Heinrich Mattle

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: January 1, 2018
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-11

Locations

SE (1); DE (1); DK (1); ES (1); IE (1)