Overview

This trial is active, not recruiting.

Condition ischemic stroke
Treatment embotrap® revascularization device
Sponsor Neuravi Limited
Start date November 2014
End date October 2016
Trial size 40 participants
Trial identifier NCT02190552, CIP001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
The EmboTrap® Revascularization Device is the investigational device
embotrap® revascularization device EmboTrap

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Time to Revascularization
time frame: Day 1
Mortality post procedure
time frame: 7 and 90(±14) days post procedure
Serious Adverse Device related effects (SADE)
time frame: 24(-8/+12) hours Post Procedure
Symptomatic ICH
time frame: 24(-8/+12) hours Post Procedure
Clinical outcome at 90 days
time frame: 90(±14) days Post Procedure
Rate of New Territory Embolization
time frame: 24(-8/+12) hours Post Procedure
Evidence of Infarction
time frame: 24(-8/+12) hours Post Procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
Principal investigator Dr. Tommy Andersson
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Neuravi Limited.