Brain AneurysmCLARYSNCT02687607
CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
An observational study of Brain Aneurysm, run by Microvention-Terumo, Inc. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- WEB Aneurysm Embolization System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to 4 Dec 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
- 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.
Who cannot join
- 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
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- 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
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLinical Assessment of WEB® Device in Ruptured aneurYSms
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.
Read the 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.
- Conditions
- Brain Aneurysm
- Being tested
- WEB Aneurysm Embolization System
- Keywords
- Endovascular, Brain aneurysm, Ruptured aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB Aneurysm Embolization SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| WEB Aneurysm Embolization System | Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms. Receives: Device: WEB Aneurysm Embolization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
- 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.
Measured: 1 month
Secondary outcomes (1)
Aneurysm occlusion
Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion10 Oct 2017
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Spelle, MD, PhD, Principal investigator, CHU Bicetre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687607
- Sponsor's protocol ID
- CP15-001
- Acronym
- CLARYS
- Status last verified
- Jan 2023
- First submitted
- 16 Feb 2016
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLinical Assessment of WEB® Device in Ruptured aneurYSms
- ClinicalTrials.gov ID
- NCT02687607
- Acronym / sponsor ID
- CLARYS / CP15-001
- Conditions
- Brain Aneurysm
- Keywords
- Endovascular, Brain aneurysm, Ruptured aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WEB Aneurysm Embolization System | – | Device: WEB Aneurysm Embolization SystemSubjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEB Aneurysm Embolization System | Device | WEB Aneurysm Embolization System |
Primary outcome
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.
1 secondary outcome
Aneurysm occlusion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter studyLink provided by the sponsor.
- 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 studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Spelle, MD, PhD principal investigator
CHU Bicetre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aneurysm, run by Microvention-Terumo, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Bleed rate after treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.