- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02190552
Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)
A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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:
- 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.
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Revascularisation Following the Use of the Neuravi Device.
Tidsramme: Day 1
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to Revascularization
Tidsramme: Day 1
|
Defined as time from groin puncture to visualization of final angiographic result.
|
Day 1
|
Mortality Post Procedure
Tidsramme: 7 and 90(±14) days post procedure
|
All procedure related mortality (i.e.
directly traceable to a procedure related SAE).
|
7 and 90(±14) days post procedure
|
Serious Adverse Device Related Effects (SADE)
Tidsramme: 24(-8/+12) hours Post Procedure
|
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
|
Symptomatic ICH
Tidsramme: 24(-8/+12) hours Post Procedure
|
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
|
Clinical Outcome at 90 Days
Tidsramme: 90(±14) days Post Procedure
|
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
|
Rate of New Territory Embolization
Tidsramme: 24(-8/+12) hours Post Procedure
|
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
|
Evidence of Infarction
Tidsramme: 24(-8/+12) hours Post Procedure
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dr. Tommy Andersson, Karolinska Institutet
- Ledende efterforsker: Prof. Dr. Heinrich Mattle, University Hospital Inselspital, Berne
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIP001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med EmboTrap® revaskulariseringsenhed
-
Neuravi Inc.AfsluttetIskæmi | SlagIrland, Forenede Stater, Belgien, Tyskland
-
Niguarda HospitalNeuravi LimitedRekrutteringAkut iskæmisk slagtilfældeItalien
-
Cerenovus, Part of DePuy Synthes Products, Inc.RekrutteringCerebralt slagtilfældeForenede Stater, Belgien, Israel, Tyskland, Schweiz, Frankrig, Det Forenede Kongerige