Analysis of Revascularisation in Ischemic Stroke With EmboTrap

Ischemic Stroke Clinical Trial

— ARISE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02190552
• Other study ID #: CIP001
• Status: Terminated
• Start date: November 2014
• Est. completion date: January 2018

Study information

• Verified date: November 2018
• Source: Neuravi Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• EmboTrap® Revascularization Device

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Germany	Universitätsklinikum Kiel	Kiel
Ireland	Beaumont Hospital	Dublin
Spain	Hospital Clinico de Barcelona	Barcelona
Sweden	Karolinska Institutet	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Neuravi Limited

Countries where clinical trial is conducted

Denmark,  Germany,  Ireland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Revascularization	Defined as time from groin puncture to visualization of final angiographic result.	Day 1
Secondary	Mortality Post Procedure	All procedure related mortality (i.e. directly traceable to a procedure related SAE).	7 and 90(±14) days post procedure
Secondary	Serious Adverse Device Related Effects (SADE)	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.	24(-8/+12) hours Post Procedure
Secondary	Symptomatic ICH	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.; The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.	24(-8/+12) hours Post Procedure
Secondary	Clinical Outcome at 90 Days	A good clinical outcome will be judged to be a mRS score of =2 at 90(±14) days.; mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms.; mRS 1 = No significant disability.; mRS 2 = Slight disability.; mRS 3 = Moderate disability.; mRS 4 = Moderately severe disability.; mRS 5 = Severe disability.; mRS 6 = Dead.	90(±14) days Post Procedure
Secondary	Rate of New Territory Embolization	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.	24(-8/+12) hours Post Procedure
Secondary	Evidence of Infarction	Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.	24(-8/+12) hours Post Procedure

External Links

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