Trial record 5 of 211 for:
Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)
Verified July 2014 by Neuravi Limited
Information provided by (Responsible Party):
First received: July 10, 2014
Last updated: July 21, 2014
Last verified: July 2014
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.
Device: EmboTrap® Revascularization Device
||Observational Model: Cohort
Time Perspective: Prospective
||A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
Device: EmboTrap® Revascularization Device
Other Name: EmboTrap
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Aarhus University Hospital
|Aarhus, Denmark |
|Copenhagen, Denmark |
|Hôpital Gui de Chauliac
|Montpellier, France |
|Paris, France |
|Augsburg, Germany |
|Cologne, Germany |
|Kiel, Germany |
|Dublin, Ireland |
|Hospital Clinico de Barcelona
|Barcelona, Spain |
|Hospital Virgen de la Arreixaca
|Murcia, Spain |
|Solna, Sweden, 17176 |
|Bern, Switzerland |
|Hopitaux Universitaires de Geneve
|Genéve, Switzerland |
||Dr. Tommy Andersson
||Prof. Dr. Heinrich Mattle
||University Hospital Inselspital, Berne
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 10, 2014
||July 21, 2014
||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
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Health and Medicines Authority
Keywords provided by Neuravi Limited:
EmboTrap® Revascularization Device
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 23, 2014
Central Nervous System Diseases
Nervous System Diseases