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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ruptured and Unruptured Intracranial Aneurysms
• Intervention / Treatment: Device: WEB aneurysm embolization system

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ruptured or unruptured intracranial aneurysms.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with ruptured or unruptured intracranial aneurysms	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recording the use of additional devices during treatment.	Possible additional devices are stent, coils, flow diverter	during index-procedure
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)	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
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
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
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
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
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
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.	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

Collaborators and Investigators

• Sponsor: Medical Therapy Solutions
• Collaborators: Archer Research
• Investigators: Principal Investigator: Maurits Voormolen, Prof Dr, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: MTS-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No