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

• ClinicalTrials.gov Identifier: NCT03379714
• Recruitment Status: Withdrawn
• First Posted: December 20, 2017
• Last Update Posted: June 1, 2018
• Sponsor: Medical Therapy Solutions
• Collaborator: Archer Research
• Information provided by (Responsible Party): Medical Therapy Solutions

Study Description

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.

Condition or disease	Intervention/treatment
Ruptured and Unruptured Intracranial Aneurysms	Device: WEB aneurysm embolization system

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Official Title: Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study
• Estimated Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: January 31, 2022

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Determination of anatomic outcome [ Time Frame: at 6 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

2. Determination of anatomic outcome [ Time Frame: 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 :

1. Determination of procedural complications (Adverse events) during the operation [ Time Frame: 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.
2. Recording the use of additional devices during treatment. [ Time Frame: during index-procedure ]
   Possible additional devices are stent, coils, flow diverter
3. Determination of the occurrence of post-procedural symptomatic thromboembolic events [ Time Frame: up to 24 months follow-up ]
4. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) [ Time Frame: At baseline ]

   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.
5. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) [ Time Frame: at 6 to 8 weeks 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.
6. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) [ Time Frame: at 6 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.
7. Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) [ Time Frame: 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.
8. Fisher grade (severity of intracranial SAH) for ruptured aneurysms. [ Time Frame: 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.

9. Determination of technical success of the device [ Time Frame: 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).
10. Determination of overall mortality [ Time Frame: up to 24 months ]
11. Recording of intracranial haemorrhage during follow-up [ Time Frame: up to 24 months ]
12. Recording the need for re-intervention during follow-up. [ Time Frame: up to 24 months ]
13. Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms. [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with ruptured or unruptured intracranial aneurysms.

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).

Contacts and Locations

Locations

Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium, 2650

Sponsors and Collaborators

Medical Therapy Solutions

Archer Research

Investigators

• Principal Investigator: Maurits Voormolen, Prof Dr; Study Principal Investigator

More Information

Additional Information:

• Responsible Party: Medical Therapy Solutions
• ClinicalTrials.gov Identifier: NCT03379714
• Other Study ID Numbers: MTS-02
• First Posted: December 20, 2017
• Last Update Posted: June 1, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Intracranial Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases