Brain AneurysmNCT01975233
WEB French Observatory of the WEB Aneurysm Embolization System
An observational study of Brain Aneurysm, run by Microvention-Terumo, Inc. at 10 sites in France.
Trial summary
An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- WEB Aneurysm Embolization System
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 10 sitesFrance
- Study dates
- Nov 2012to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
Who may be able to join
- The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
- Subject must be ≥ 18 years of age;
- Subject must have an intracranial aneurysm requiring treatment according to a multidisciplinary decision. If the subject has an additional aneurysm requiring treatment, the additional aneurysm must not require treatment within 30 days of the index procedure;
- Aneurysm to be treated must have the following characteristics:
- Morphology - saccular ii. Location:
- Basilar apex (BA), or
Show all 15Show fewer
- Middle cerebral artery (MCA) bifurcation, or
- Internal carotid artery (ICA) terminus
- Anterior communicating artery (ACom)
- Anterior cerebral Artery (ACA) iii. Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use iv. Dome-to-Neck (DN) ratio ≥ 1.0
- 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 must sign and date CPP and/or CCTIRS/CNIL approved written informed consent prior to initiation of any clinical evaluation procedures, including screening procedures (if unable to sign for self, legal representative may do so where applicable).
- Additional inclusion criterion for ruptured aneurysms:
- For subjects with ruptured aneurysm: subject has ruptured aneurysm with Hunt \& Hess Score of I, II, or III
Who cannot join
- 1. Subject is greater than 75 years of age; 2. Subject has more than one aneurysm requiring treatment within 30 days of index procedure; 3. Subject is female and pregnant or breast-feeding; 4. Subject has a known coagulopathy; 5. Subject has a known hemoglobinopathy or thrombocytopathy; 6. Subject has lesion with characteristics unsuitable for endovascular treatment; 7. Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device; 8. Subject exhibits ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution within 30 days prior to enrollment; 9. Subject exhibits clinical or angiographic evidence of vasospasm; 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 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 2 years due to other illness or condition (in addition to an intracranial aneurysm);
- Additional Exclusion Criteria for unruptured aneurysms:
- 15. Subject has Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of subarachnoid/intracranial hemorrhage on presentation; 16. Subject has any circulatory, neurovascular, or cardiovascular medical conditions that have resulted in neurological symptoms;
- Additional Exclusion Criteria for ruptured aneurysms:
- 17. Subject has a ruptured aneurysm and Hunt \& Hess Score of IV or V;
- Additional Imaging Exclusion Criteria:
- 18. Subject has CT or MRI evidence of intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation; 19. Subject has angiographic evidence of vasculitis; 20. Microcatheter could not reach Subject's aneurysm to allow necessary access to treat with clinical evaluation device
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Pellegrin
Bordeaux, 33076
CHU Côte de Nacre
Caen, 14033
CHU Beaujon
Clichy, 92110
Hôpital Neurologique Pierre Wertheimer
Lyon, 69500
Hôpital Nord Laennec
Nantes, 44093
CHU La Miletrie
Potiers, 86021
CHU Reims - Hôpital Maison-Blanche
Reims, 51092
CHU Pontchailloux
Rennes, 35033
CHU Purpan
Toulouse, 31059
CHU Bretonneau
Tours, 37000
About this study
Official title: WEB French Observatory
An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
Read the detailed description
Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques.
Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects.
Subjects will be followed per Institution's standard of care.
- Conditions
- Brain Aneurysm
- Being tested
- WEB Aneurysm Embolization System
- Keywords
- Endovascular, Brain Aneurysm
- 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
WEB Aneurysm Embolization System
| Study group | Role | What they receive |
|---|---|---|
| WEB Aneurysm Embolization System | Subjects aged ≥ 18 years, but ≤ 75 years requiring treatment for 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.
Durability of aneurysm occlusion
The following efficacy assessments will be performed to assess the efficacy of the WEB Aneurysm Embolization System in the endovascular treatment of aneurysms.
- Durability of occlusion compared to post-procedure imaging
Durability is defined as:
- No worsening of Raymond Class from post-procedure result to follow-up result and ii. Not classified as "Recanalized"
Measured: 12 months
Secondary outcomes (1)
Recurrence/recanalization rate
Rate of aneurysm recanalization
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 posted4 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionDec 2016
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Pierot, MD PhD, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975233
- Sponsor's protocol ID
- 12001
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2013
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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
- WEB French Observatory
- ClinicalTrials.gov ID
- NCT01975233
- Acronym / sponsor ID
- 12001
- Conditions
- Brain Aneurysm
- Keywords
- Endovascular, Brain Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Nov 2013 (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 post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
Detailed description
Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques.
Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects.
Subjects will be followed per Institution's standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WEB Aneurysm Embolization System | – | Device: WEB Aneurysm Embolization SystemSubjects aged ≥ 18 years, but ≤ 75 years requiring treatment for intracranial aneurysms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
Key inclusion criteria (15 listed)
- The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
- Subject must be ≥ 18 years of age;
- Subject must have an intracranial aneurysm requiring treatment according to a multidisciplinary decision. If the subject has an additional aneurysm requiring treatment, the additional aneurysm must not require treatment within 30 days of the index procedure;
- Aneurysm to be treated must have the following characteristics:
- Subject must be considered by the physician to be available for subsequent visits;
Key exclusion criteria (7 listed)
- 1. Subject is greater than 75 years of age; 2. Subject has more than one aneurysm requiring treatment within 30 days of index procedure; 3. Subject is female and pregnant or breast-feeding; 4. Subject has a known coagulopathy; 5. Subject has a known hemoglobinopathy or thrombocytopathy; 6. Subject has lesion with characteristics unsuitable for endovascular treatment; 7. Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device; 8. Subject exhibits ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution within 30 days prior to enrollment; 9. Subject exhibits clinical or angiographic evidence of vasospasm; 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 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 2 years due to other illness or condition (in addition to an intracranial aneurysm);
- 15. Subject has Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of subarachnoid/intracranial hemorrhage on presentation; 16. Subject has any circulatory, neurovascular, or cardiovascular medical conditions that have resulted in neurological symptoms;
- 17. Subject has a ruptured aneurysm and Hunt \& Hess Score of IV or V;
- 18. Subject has CT or MRI evidence of intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation; 19. Subject has angiographic evidence of vasculitis; 20. Microcatheter could not reach Subject's aneurysm to allow necessary access to treat with clinical evaluation device
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 SystemWEB Aneurysm Embolization System | Device | WEB Aneurysm Embolization System |
Primary outcome
Durability of aneurysm occlusion
Time frame: 12 months
The following efficacy assessments will be performed to assess the efficacy of the WEB Aneurysm Embolization System in the endovascular treatment of aneurysms. 1. Durability of occlusion compared to post-procedure imaging Durability is defined as: i. No worsening of Raymond Class from post-procedure result to follow-up result and ii. Not classified as "Recanalized"
1 secondary outcome
Recurrence/recanalization rate
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 and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory).Link provided by the sponsor.
- WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory.Link provided by the sponsor.
- WEB Treatment of Intracranial Aneurysms: Feasibility, Complications, and 1-Month Safety Results with the WEB DL and WEB SL/SLS in the French Observatory.Link provided by the sponsor.
- Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective Multicenter Series: 2-Year Follow-upLink provided by the sponsor.
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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 Pierot, MD PhD principal investigator
CHU de Reims
10 sites 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 10 sites 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 15 inclusion and 7 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 10 sites 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?
Durability of aneurysm occlusion (time frame: 12 months). 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.