Clinical trial NCT03379714: Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Official title: Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ruptured and Unruptured Intracranial Aneurysms
Lead sponsor: Medical Therapy Solutions
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2017-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ruptured or unruptured intracranial aneurysms.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient is capable to undergo general anaesthesia.
3. 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.
4. Patient has a ruptured or unruptured intracranial aneurysm requiring endovascular treatment.
5. Aneurysm with dome-to-neck ratio ≥ 1.
6. Aneurysm size favourable for WEB implantation (aneurysm width \< 10 mm or aneurysm width \> 3mm).

Exclusion Criteria:

1. Patient is pregnant.
2. Patient has renal insufficiency (GRF \< 45 ml/min/1.73 m2).
3. 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).

Primary outcomes:
measure: Determination of anatomic outcome
timeFrame: at 6 months
measure: Determination of anatomic outcome
timeFrame: at 24 months
Secondary outcomes:
measure: Determination of procedural complications (Adverse events) during the operation
timeFrame: during index-procedure
measure: Recording the use of additional devices during treatment.
timeFrame: during index-procedure
measure: Determination of the occurrence of post-procedural symptomatic thromboembolic events
timeFrame: up to 24 months follow-up
measure: Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
timeFrame: At baseline
measure: Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
timeFrame: at 6 to 8 weeks follow-up
measure: Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
timeFrame: at 6 months follow-up
measure: Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
timeFrame: at 24 months follow-up
measure: Fisher grade (severity of intracranial SAH) for ruptured aneurysms.
timeFrame: at baseline
measure: Determination of technical success of the device
timeFrame: during index-procedure
measure: Determination of overall mortality
timeFrame: up to 24 months
measure: Recording of intracranial haemorrhage during follow-up
timeFrame: up to 24 months
measure: Recording the need for re-intervention during follow-up.
timeFrame: up to 24 months
measure: Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms.
timeFrame: baseline
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: Study Principal Investigator
name: Maurits Voormolen, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: