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CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS)

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ClinicalTrials.gov Identifier: NCT02687607
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc

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.

Condition or disease Intervention/treatment
Brain Aneurysm Device: WEB Aneurysm Embolization System

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CLinical Assessment of WEB® Device in Ruptured aneurYSms
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Tears

Group/Cohort Intervention/treatment
WEB Aneurysm Embolization System
Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.
Device: WEB Aneurysm Embolization System



Primary Outcome Measures :
  1. Re-Bleed rate after treatment [ Time Frame: 1 month ]

    Re-bleeding rate after treatment of the target aneurysm with WEB, during the period extending from post-procedure up to 1 month.

    Definitions:

    1. Re-bleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
    2. Screening for re-bleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.

    Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.



Secondary Outcome Measures :
  1. Aneurysm occlusion [ Time Frame: 12 months ]
    Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687607


Contacts
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Contact: Patricia Boyer 33 0670139498 patriciab@sequentmedical.com
Contact: Amy Walters (949) 923-9400 amyw@sequentmedical.com

Locations
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France
Service de Neuroradiologie Recruiting
Bicetre, Le Kremlin-Bicetre, France, 94270
Principal Investigator: Laurent Spelle, MD, PhD         
Sponsors and Collaborators
Sequent Medical, Inc
Investigators
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Principal Investigator: Laurent Spelle, MD, PhD CHU Bicetre

Additional Information:

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Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT02687607     History of Changes
Other Study ID Numbers: CP15-001
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sequent Medical, Inc:
Endovascular
Brain aneurysm
Ruptured aneurysm

Additional relevant MeSH terms:
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Aneurysm
Rupture
Intracranial Aneurysm
Aneurysm, Ruptured
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases