Clinical trial NCT03312725: Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System
Official title: Mid-term 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: TERMINATED
Conditions: Ruptured and Unruptured Intracranial Aneurysms
Lead sponsor: Medical Therapy Solutions
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2017-10-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
timeFrame: at 6 months follow-up
measure: Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
timeFrame: at 24 months follow-up
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 to occlude the aneurysm
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 6 to 8 weeks follow-up
measure: 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.
timeFrame: During index-procedure
measure: Determination of 30 day mortality
timeFrame: up to 30 days
measure: Determination of overall mortality
timeFrame: up to 24 months
measure: Recording of intracranial haemorrhage during follow-up
timeFrame: up to 24 months
measure: Need for repeat treatment during follow-up
timeFrame: up to 24 months
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
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Luc Defreyne
role: PRINCIPAL_INVESTIGATOR
References: