Clinical trial NCT02687607: CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
Official title: CLinical Assessment of WEB® Device in Ruptured aneurYSms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aneurysm
Keywords: Endovascular
Brain aneurysm
Ruptured aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this Registry

Brief summary: An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

Detailed description: All eligible subjects presenting to the participating Registry Center will be considered for entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will be enrolled.

An intermediary analysis will be performed when the first forty (40) subjects reaching the planned one month follow-up.

subjects will be followed per Institution's standard of care.

Eligibility criteria: Inclusion Criteria:

1. The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this Registry
2. Subject must be ≥ 18 years and \< 80 years of age
3. Subject must have a single intracranial aneurysm ruptured within 30 days requiring treatment according to a multidisciplinary decision Definition: For the purposes of this study a ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days.
4. If the subject has one or more additional aneurysm, the additional aneurysm must not require treatment in emergency or within 30 days of the index procedure
5. Subject with Hunt \& Hess Score of I, II or III
6. Conventional or Flat-panel CT is performed within 6hrs prior to femoral puncture (or just before WEB placement if any clinical worsening is noted before the treatment) to assess absence of re-bleeding prior the treatment
7. Aneurysm to be treated must have the following characteristics i. Morphology - saccular ii. Location

   * Basilar apex (BA), or
   * Middle cerebral artery (MCA) bifurcation, or
   * Internal carotid artery (ICA) terminus, or
   * Anterior communicating artery (ACom), or
   * Anterior cerebral Artery (ACA), or
   * Posterior Communicating (PCom) iii. Diameter and height of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use: Max width diameter 10mm iv. Aneurysm is a priori intended to be treated only with WEB
8. Subject must be considered by the physician to be available for subsequent visits
9. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
10. Subject, or its legal representative, must have received information regarding the data collection and data protection within this clinical evaluation, or must have signed the informed consent when locally mandatory.

Exclusion Criteria:

1. Subject is greater than 80 years of age
2. Subject has a Hunt \& Hess Score of IV or V
3. Subject has more than one aneurysm requiring treatment within 30 days of index procedure
4. Maximum aneurysm width is \>10mm
5. Subject is female and pregnant or breast-feeding
6. Subject has a known coagulopathy
7. Subject has a known hemoglobinopathy or thrombocytopathy
8. Subject has lesion with characteristics unsuitable for endovascular treatment
9. Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device
10. Subject has physical, neurologic or psychiatric conditions, which preclude Subject's ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
11. Subject has known hypersensitivity, which can not be treated, to any component of the clinical evaluation device, procedural materials, or medications commonly used during the procedure
12. Subject has received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
13. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial
14. Subject has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm) Imaging Exclusion criteria
15. An additional aneurysm need to be treated during the index procedure
16. Microcatheter cannot reach Subject's aneurysm to allow necessary access to treat with WEB.

Primary outcomes:
measure: Re-Bleed rate after treatment
timeFrame: 1 month
Secondary outcomes:
measure: Aneurysm occlusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin-Bicetre
country: France
facility: Service de Neuroradiologie
Study officials:
affiliation: CHU Bicetre
name: Laurent Spelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: