CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms

NCT02687607 | Completed

• 1 other identifier: CP15-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Aneurysm

Keywords

Endovascular; Brain aneurysm; Ruptured aneurysm

Outcome Measures

Primary Outcomes (1)

• Re-Bleed rate after treatment

  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.

  1 month

Secondary Outcomes (1)

• Aneurysm occlusion

  12 months

Study Arms (1)

WEB Aneurysm Embolization System

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.

Device: WEB Aneurysm Embolization System

Interventions

WEB Aneurysm Embolization System DEVICE

WEB Aneurysm Embolization System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Subject must be ≥ 18 years and \< 80 years of age
• 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.
• 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
• Subject with Hunt \& Hess Score of I, II or III
• 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
• 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
• Subject must be considered by the physician to be available for subsequent visits
• Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule

You may not qualify if:

• Subject is greater than 80 years of age
• Subject has a Hunt \& Hess Score of IV or V
• Subject has more than one aneurysm requiring treatment within 30 days of index procedure
• Maximum aneurysm width is \>10mm
• Subject is female and pregnant or breast-feeding
• Subject has a known coagulopathy
• Subject has a known hemoglobinopathy or thrombocytopathy
• Subject has lesion with characteristics unsuitable for endovascular treatment
• Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device
• 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
• 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
• Subject has received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
• Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial
• An additional aneurysm need to be treated during the index procedure
• Microcatheter cannot reach Subject's aneurysm to allow necessary access to treat with WEB.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

Service de Neuroradiologie

Le Kremlin-Bicêtre, 94270, France

Location

Related Links

• CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study
• CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Laurent Spelle, MD, PhD

  CHU Bicetre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 22, 2016
• Study Start: January 1, 2016
• Primary Completion: October 10, 2017
• Study Completion: December 4, 2018
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)