Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System

Withdrawn

• Conditions: Ruptured and Unruptured Intracranial Aneurysms
• Interventions: Device: WEB aneurysm embolization system

• Registration Number: NCT03379714
• Lead Sponsor: Medical Therapy Solutions

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-20
• Study Start: 2018-01-01
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ruptured or unruptured intracranial aneurysms	WEB aneurysm embolization system	-

Primary Outcome Measures

Name	Time	Method
Determination of anatomic outcome	at 24 months	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

Secondary Outcome Measures

Name	Time	Method
Determination of procedural complications (Adverse events) during the operation	during index-procedure	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.
Recording the use of additional devices during treatment.	during index-procedure	Possible additional devices are stent, coils, flow diverter
Determination of the occurrence of post-procedural symptomatic thromboembolic events	up to 24 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)	at 24 months follow-up	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.
Determination of technical success of the device	during index-procedure	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).
Fisher grade (severity of intracranial SAH) for ruptured aneurysms.	at baseline	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.
Determination of overall mortality	up to 24 months
Recording of intracranial haemorrhage during follow-up	up to 24 months
Recording the need for re-intervention during follow-up.	up to 24 months
Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms.	baseline	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

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium