Ruptured and Unruptured Intracranial AneurysmsNCT03312725
Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
An observational study of Ruptured and Unruptured Intracranial Aneurysms, run by Medical Therapy Solutions at 1 site in Belgium.
Trial summary
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ruptured and Unruptured Intracranial Aneurysms
- What is being tested?
- WEB aneurysm embolization system
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2017to 26 Jun 2018
- How long will I take part?
- 24 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: Patients with ruptured or unruptured intracranial aneurysms.
Who may be able to join
- Patient is between 18 and 80 years old.
- Patient must sign and date the informed consent form <72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf.
- Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment.
- Aneurysm with dome-to-neck ratio ≥ 1.
Who cannot join
- Aneurysm size unfavourable for WEB implantation (aneurysm width > 10 mm or aneurysm width < 3mm).
- Patient with Hunt and Hess grades 4 or 5.
- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- Parent vessel occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.
- Being tested
- WEB aneurysm embolization system
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB aneurysm embolization systemDevice
The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/iridium radiopaque markers.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ruptured or unruptured intracranial aneurysms. | Not described Receives: Device: WEB aneurysm embolization system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
WEB Occlusion Scale:
WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
Measured: at 6 months follow-up
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
WEB Occlusion Scale:
WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
Measured: at 24 months follow-up
Secondary outcomes (11)
Determination of procedural complications (Adverse events) during the operation
Procedural complications: aneurysm rupture, dissection, thromboembolic events (symptomatic and non-symptomatic), device protrusion through the neck of the aneurysm inside the parent artery, detachment problem, device stuck in microcatheter, bleeding.
Measured: During index-procedure
Recording the use of additional devices during treatment to occlude the aneurysm
Possible additional devices are stent, coils, flow diverter
Measured: During index-procedure
Determination of the occurrence of post-procedural symptomatic thromboembolic events
Measured: up to 24 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: at 6 to 8 weeks follow-up
Determination of the technical success of the device defined as device deployment in the target aneurysm as intended by the investigator with complete apposition against the aneurysm wall.
Measured: During index-procedure
Determination of 30 day mortality
Measured: up to 30 days
Determination of overall mortality
Measured: up to 24 months
Recording of intracranial haemorrhage during follow-up
Measured: up to 24 months
Need for repeat treatment during follow-up
Measured: up to 24 months
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: at 6 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: at 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Feb 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured and Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Medical Therapy Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
- Investigators
- Luc Defreyne, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312725
- Sponsor's protocol ID
- MTS-01
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study
- ClinicalTrials.gov ID
- NCT03312725
- Acronym / sponsor ID
- MTS-01
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical Therapy SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 18 Oct 2017 (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.
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ruptured or unruptured intracranial aneurysms. | – | Device: WEB aneurysm embolization system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ruptured or unruptured intracranial aneurysms.
Key inclusion criteria (4 listed)
- Patient is between 18 and 80 years old.
- Patient must sign and date the informed consent form <72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf.
- Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment.
- Aneurysm with dome-to-neck ratio ≥ 1.
Key exclusion criteria (4 listed)
- Aneurysm size unfavourable for WEB implantation (aneurysm width > 10 mm or aneurysm width < 3mm).
- Patient with Hunt and Hess grades 4 or 5.
- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- Parent vessel occlusion.
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 systemThe WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/iridium radiopaque markers. | Device | Patients with ruptured or unruptured intracranial aneurysms. |
Primary outcome
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
Time frame: at 6 months follow-up
WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
Time frame: at 24 months follow-up
WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
11 secondary outcomes
Determination of procedural complications (Adverse events) during the operation
Time frame: During index-procedure
Recording the use of additional devices during treatment to occlude the aneurysm
Time frame: During index-procedure
Determination of the occurrence of post-procedural symptomatic thromboembolic events
Time frame: up to 24 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
Time frame: at 6 to 8 weeks follow-up
Determination of the technical success of the device defined as device deployment in the target aneurysm as intended by the investigator with complete apposition against the aneurysm wall.
Time frame: During index-procedure
Determination of 30 day mortality
Time frame: up to 30 days
Determination of overall mortality
Time frame: up to 24 months
Recording of intracranial haemorrhage during follow-up
Time frame: up to 24 months
Need for repeat treatment during follow-up
Time frame: up to 24 months
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
Time frame: at 6 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
Time frame: at 24 months follow-up
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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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.
Luc Defreyne principal investigator
University Hospital, Ghent
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 Ruptured and Unruptured Intracranial Aneurysms, run by Medical Therapy Solutions at 1 site in Belgium.
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: stopped early, as of the sponsor's last update on 10 Oct 2018. 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 Belgium. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA (time frame: at 6 months follow-up). 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?
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 10 Oct 2018.