Brain AneurysmCLEVERNCT03844334
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
An observational study of Brain Aneurysm, run by Microvention-Terumo, Inc. at 4 sites in 3 countries.
Trial summary
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment. 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
- 163 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Mar 2019to 30 Aug 2022
- 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 study
Who may be able to join
- Subject must be ≥ 18 years of age and ≤80 years of age
- Subject must have an intracranial aneurysm (IA),
- Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
- For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III
Who cannot join
- Subject has an IA with characteristics unsuitable for endovascular treatment
- Subject's index IA was previously treated
- Subject has stroke-in-evolution within the prior 30 days
- An additional aneurysm must be treated during the procedure
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Purpan
Toulouse, 31059
About this study
Official title: CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
Read the detailed description
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.
Subjects will be followed per Institution's standard of care.
- Conditions
- Brain Aneurysm
- Being tested
- WEB Aneurysm Embolization System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB Aneurysm Embolization SystemDevice
Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm occlusion
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.
- class I: complete obliteration
- class II: residual neck
- class III: residual aneurysm
Measured: 12 months
Incidence of major stroke or neurological deaths
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start21 Mar 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844334
- Sponsor's protocol ID
- CIP EMEA 18-02
- Acronym
- CLEVER
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2019
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Mohlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, Cognard C. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms. J Neurointerv Surg. 2024 Nov 22;16(12):1299-1306. doi: 10.1136/jnis-2023-020866.
PubMed 37914392
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
- ClinicalTrials.gov ID
- NCT03844334
- Acronym / sponsor ID
- CLEVER / CIP EMEA 18-02
- Conditions
- Brain Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 18 Feb 2019 (actual)
- 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.
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
Detailed description
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.
Subjects will be followed per Institution's standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 study
Key inclusion criteria (4 listed)
- Subject must be ≥ 18 years of age and ≤80 years of age
- Subject must have an intracranial aneurysm (IA),
- Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
- For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III
Key exclusion criteria (4 listed)
- Subject has an IA with characteristics unsuitable for endovascular treatment
- Subject's index IA was previously treated
- Subject has stroke-in-evolution within the prior 30 days
- An additional aneurysm must be treated during the procedure
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 SystemSubjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms. | Device | – |
Primary outcome
Aneurysm occlusion
Time frame: 12 months
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. * class I: complete obliteration * class II: residual neck * class III: residual aneurysm
Incidence of major stroke or neurological deaths
Time frame: 12months
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
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 24 Jan 2024.
- Derived from this study: PubMed 37914392Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Mohlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, Cognard C. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms. J Neurointerv Surg. 2024 Nov 22;16(12):1299-1306. doi: 10.1136/jnis-2023-020866.
- CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysmsLink provided by the sponsor.
Related trials for Brain Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: 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 4 sites in 3 countries.
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 4 inclusion and 4 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Hungary. 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?
Aneurysm occlusion (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844334, which also lists 1 linked publication.
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 24 Jan 2024.