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

Ruptured and Unruptured Intracranial Aneurysms Clinical Trial

Official title:

Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03379714
• Other study ID #: MTS-02
• Status: Withdrawn
• Start date: January 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2017
• Source: Medical Therapy Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Ruptured and Unruptured Intracranial Aneurysms

Intervention

Device:
• WEB aneurysm embolization system
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.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Medical Therapy Solutions	Archer Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 6 months
Primary	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	at 24 months
Secondary	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.	during index-procedure
Secondary	Recording the use of additional devices during treatment.	Possible additional devices are stent, coils, flow diverter	during index-procedure
Secondary	Determination of the occurrence of post-procedural symptomatic thromboembolic events		up to 24 months follow-up
Secondary	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.	At baseline
Secondary	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.	at 6 to 8 weeks follow-up
Secondary	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.	at 6 months follow-up
Secondary	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.	at 24 months follow-up
Secondary	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.	at baseline
Secondary	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).	during index-procedure
Secondary	Determination of overall mortality		up to 24 months
Secondary	Recording of intracranial haemorrhage during follow-up		up to 24 months
Secondary	Recording the need for re-intervention during follow-up.		up to 24 months
Secondary	Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms.	Hunt and Hess scale: asymptomatic or minimal headache and slight neck stiffness, 70% survival; moderate to severe headache; neck stiffness; no neurologic deficit except cranial nerve palsy; 60% survival; drowsy; minimal neurologic deficit; 50% survival; stuporous; moderate to severe hemiparesis; possibly early decerebrate rigidity and vegetative disturbances; 20% survival; deep coma; decerebrate rigidity; moribund;10% survival	baseline