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Ruptured and Unruptured Intracranial AneurysmsNCT03379714

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 years and older
What is being tested?
WEB aneurysm embolization system
Type of treatment
Medical device
How many people
0 participants
Where
1 siteBelgium
Study dates
1 Jan 2018to 31 Jan 2022
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 years and older
  • 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 at least 18 years old.
  • Patient is capable to undergo general anaesthesia.
  • Patient must sign and date the informed consent form 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 or unruptured intracranial aneurysm requiring endovascular treatment.
  • Aneurysm with dome-to-neck ratio ≥ 1.
  • Aneurysm size favourable for WEB implantation (aneurysm width < 10 mm or aneurysm width > 3mm).

Who cannot join

  • Patient is pregnant.
  • Patient has renal insufficiency (GRF < 45 ml/min/1.73 m2).
  • Patient is unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: 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 groups in NCT03379714
Study groupRoleWhat they receive
Patients with ruptured or unruptured intracranial aneurysmsNot described
Receives: Device: WEB aneurysm embolization system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

Secondary outcomes (13)

  1. 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

  2. Recording the use of additional devices during treatment.

    Possible additional devices are stent, coils, flow diverter

    Measured: during index-procedure

  3. Determination of the occurrence of post-procedural symptomatic thromboembolic events

    Measured: up to 24 months follow-up

  4. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: At baseline

  5. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: at 6 to 8 weeks follow-up

  6. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: at 6 months follow-up

  7. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: at 24 months follow-up

  8. Fisher grade (severity of intracranial SAH) for ruptured aneurysms.

    Fisher grade:

    1 No haemorrhage evident. 2 Subarachnoid haemorrhage less than 1mm thick. 3 Subarachnoid haemorrhage more than 1mm thick. 4 Subarachnoid haemorrhage of any thickness with intraventricular haemorrhage (IVH) or parenchymal extension.

    Measured: at baseline

  9. Determination of technical success of the device

    Technical success is defined as device deployment in the target aneurysm as intended by the investigator with adequate occlusion of the aneurysm (WOS A, B or C).

    Measured: during index-procedure

  10. Determination of overall mortality

    Measured: up to 24 months

  11. Recording of intracranial haemorrhage during follow-up

    Measured: up to 24 months

  12. Recording the need for re-intervention during follow-up.

    Measured: up to 24 months

  13. Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms.

    Hunt and Hess scale:

    1. asymptomatic or minimal headache and slight neck stiffness, 70% survival
    2. moderate to severe headache; neck stiffness; no neurologic deficit except cranial nerve palsy; 60% survival
    3. drowsy; minimal neurologic deficit; 50% survival
    4. stuporous; moderate to severe hemiparesis; possibly early decerebrate rigidity and vegetative disturbances; 20% survival
    5. deep coma; decerebrate rigidity; moribund;10% survival

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2017
  2. Study start1 Jan 2018 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Why it stopped: Sponsor decision

Resources

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
0 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03379714
Sponsor's protocol ID
MTS-02
Status last verified
Dec 2017
First submitted
13 Dec 2017
Last updated
1 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Jun 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 withdrawn before enrolling participants, so there are no results.

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 (time frame: at 6 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 NCT03379714.

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 1 Jun 2018.

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