Intracranial AneurysmWEBCASTNCT01778322
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 12 sites in 4 countries.
Trial summary
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Intracranial aneurysm embolization
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Dec 2011to Dec 2019
- 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: Subjects with: - Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use
Who may be able to join
- Must be at least 18 years of age
- Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures
Who cannot join
- Must not have clinical or angiographic evidence of vasospasm
- Must not have lesion with characteristics unsuitable for endovascular treatment
- Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
- Must not be concurrently involved in another investigational or post-market study
- Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
France5 sites
Hôpital Beaujon
Clichy, 92118
CHU Gui de Chauliac
Montpellier, 34295
CHU Reims Maison Blanche
Reims, 51092
CHU Purpan
Toulouse, 31059
CHU Bretonneau
Tours, 37000
Germany5 sites
Uniklinik Koeln
Cologne, 50937
Helios Klinikum
Erfurt, 99089
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, 60528
Klinikum Vest GmbH
Recklinghausen, 45657
Klinikum Stuttgart- Katharinenhospital
Stuttgart, 70174
About this study
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
Read the detailed description
The following parameters will be evaluated as part of this study:
- Aneurysm morphology
- Aneurysm size
- For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
- Size of the embolization device(s) used in the procedure
- Intra-procedural assessment of aneurysm occlusion and flow stasis
- Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
- Aneurysm occlusion durability
- Recanalization rate
- Device-related changes in Modified Rankin Scale from baseline
- Complications/adverse events
- Rebleed/new bleed
- Conditions
- Intracranial Aneurysm
- Being tested
- Intracranial aneurysm embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial aneurysm embolizationProcedure or surgery
Treatment of intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Index Embolization Cohort | WEB Aneurysm Embolization System Receives: Procedure: Intracranial aneurysm embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of occlusion
Evaluated by the Corelab
Measured: 6 months
Secondary outcomes (3)
Recurrence/recanalization rate
Evaluated by the Corelab, based on Raymond Roy occlusion scale
Measured: 6 months
Modified Raymond Scale
Evaluation of patient's functional level of activity by the physician
Measured: 6 months
Percentage occlusion of target aneurysm
Evaluated by the Corelab
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intracranial 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Pierot, MD, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778322
- Sponsor's protocol ID
- CP 11-001
- Acronym
- WEBCAST
- Status last verified
- Aug 2022
- First submitted
- 25 Jan 2013
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023 Jun;15(6):552-557. doi: 10.1136/neurintsurg-2021-018414. Epub 2022 Jul 8.
PubMed 35803731Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.
PubMed 32532858Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspotter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne J, Spelle L. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018 Jun;10(6):553-559. doi: 10.1136/neurintsurg-2017-013448. Epub 2017 Sep 30.
PubMed 28965106Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. 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). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.
PubMed 26552042
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
- ClinicalTrials.gov ID
- NCT01778322
- Acronym / sponsor ID
- WEBCAST / CP 11-001
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Jan 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.
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
Detailed description
The following parameters will be evaluated as part of this study:
- Aneurysm morphology
- Aneurysm size
- For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
- Size of the embolization device(s) used in the procedure
- Intra-procedural assessment of aneurysm occlusion and flow stasis
- Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
- Aneurysm occlusion durability
- Recanalization rate
- Device-related changes in Modified Rankin Scale from baseline
- Complications/adverse events
- Rebleed/new bleed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Index Embolization Cohort | – | Procedure: Intracranial aneurysm embolizationWEB Aneurysm Embolization System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with: - Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use
Key inclusion criteria (2 listed)
- Must be at least 18 years of age
- Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures
Key exclusion criteria (5 listed)
- Must not have clinical or angiographic evidence of vasospasm
- Must not have lesion with characteristics unsuitable for endovascular treatment
- Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
- Must not be concurrently involved in another investigational or post-market study
- Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
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 |
|---|---|---|
| Intracranial aneurysm embolizationTreatment of intracranial aneurysms | Procedure or surgery | Index Embolization Cohort |
Primary outcome
Durability of occlusion
Time frame: 6 months
Evaluated by the Corelab
3 secondary outcomes
Recurrence/recanalization rate
Time frame: 6 months
Modified Raymond Scale
Time frame: 6 months
Percentage occlusion of target aneurysm
Time frame: 6 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 15 Mar 2023.
- Derived from this study: PubMed 35803731Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023 Jun;15(6):552-557. doi: 10.1136/neurintsurg-2021-018414. Epub 2022 Jul 8.
- Derived from this study: PubMed 32532858Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.
- Derived from this study: PubMed 28965106Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspotter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne J, Spelle L. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018 Jun;10(6):553-559. doi: 10.1136/neurintsurg-2017-013448. Epub 2017 Sep 30.
- Derived from this study: PubMed 26552042Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. 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). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.
- 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.
- Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.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.
- Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-upLink provided by the sponsor.
- Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-upLink provided by the sponsor.
- Safety and Efficacy of Aneurysm Treatment with the WEB: Results of the WEBCAST 2 StudyLink 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 principal investigator
CHU de Reims
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 12 sites in 4 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 2 inclusion and 5 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Germany, Denmark, 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?
Durability of occlusion (time frame: 6 months). 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 NCT01778322, which also lists 4 linked publications.
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 15 Mar 2023.