WEB French Observatory of the WEB Aneurysm Embolization System

Brain Aneurysm Clinical Trial

Official title:

WEB French Observatory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975233
• Other study ID #: 12001
• Status: Completed
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2023
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.

Description:

Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques. Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects. Subjects will be followed per Institution's standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory

2. Subject must be = 18 years of age;

3. Subject must have an intracranial aneurysm requiring treatment according to a multidisciplinary decision. If the subject has an additional aneurysm requiring treatment, the additional aneurysm must not require treatment within 30 days of the index procedure;

4. Aneurysm to be treated must have the following characteristics:

i. Morphology - saccular ii. Location:

• Basilar apex (BA), or
• Middle cerebral artery (MCA) bifurcation, or
• Internal carotid artery (ICA) terminus
• Anterior communicating artery (ACom)
• Anterior cerebral Artery (ACA) iii. Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use iv. Dome-to-Neck (DN) ratio = 1.0

5. Subject must be considered by the physician to be available for subsequent visits;

6. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule;

7. Subject must sign and date CPP and/or CCTIRS/CNIL approved written informed consent prior to initiation of any clinical evaluation procedures, including screening procedures (if unable to sign for self, legal representative may do so where applicable). Additional inclusion criterion for ruptured aneurysms: For subjects with ruptured aneurysm: subject has ruptured aneurysm with Hunt & Hess Score of I, II, or III

Exclusion Criteria:

• 1. Subject is greater than 75 years of age; 2. Subject has more than one aneurysm requiring treatment within 30 days of index procedure; 3. Subject is female and pregnant or breast-feeding; 4. Subject has a known coagulopathy; 5. Subject has a known hemoglobinopathy or thrombocytopathy; 6. Subject has lesion with characteristics unsuitable for endovascular treatment; 7. Subject has vessel, tortuosity or morphology which could preclude safe access and support during treatment with clinical evaluation device; 8. Subject exhibits ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution within 30 days prior to enrollment; 9. Subject exhibits clinical or angiographic evidence of vasospasm; 10. Subject has physical, neurologic or psychiatric conditions, which preclude Subject's ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule; 11. Subject has known hypersensitivity to any component of the clinical evaluation device, procedural materials, or medications commonly used during the procedure; 12. Subject has received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial; 13. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial; 14. Subject has a life expectancy of less than 2 years due to other illness or condition (in addition to an intracranial aneurysm);

Additional Exclusion Criteria for unruptured aneurysms:

15. Subject has Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of subarachnoid/intracranial hemorrhage on presentation; 16. Subject has any circulatory, neurovascular, or cardiovascular medical conditions that have resulted in neurological symptoms;

Additional Exclusion Criteria for ruptured aneurysms:

17. Subject has a ruptured aneurysm and Hunt & Hess Score of IV or V;

Additional Imaging Exclusion Criteria:

18. Subject has CT or MRI evidence of intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation; 19. Subject has angiographic evidence of vasculitis; 20. Microcatheter could not reach Subject's aneurysm to allow necessary access to treat with clinical evaluation device

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• WEB Aneurysm Embolization System
WEB Aneurysm Embolization System

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux
France	CHU Côte de Nacre	Caen
France	CHU Beaujon	Clichy
France	Hôpital Neurologique Pierre Wertheimer	Lyon
France	Hôpital Nord Laennec	Nantes
France	CHU La Miletrie	Potiers
France	CHU Reims - Hôpital Maison-Blanche	Reims
France	CHU Pontchailloux	Rennes
France	CHU Purpan	Toulouse
France	CHU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Raymond Scale		12 months
Other	Percentage occlusion		12 months
Primary	Durability of aneurysm occlusion	The following efficacy assessments will be performed to assess the efficacy of the WEB Aneurysm Embolization System in the endovascular treatment of aneurysms.; 1. Durability of occlusion compared to post-procedure imaging; Durability is defined as: i. No worsening of Raymond Class from post-procedure result to follow-up result and ii. Not classified as "Recanalized"	12 months
Secondary	Recurrence/recanalization rate	Rate of aneurysm recanalization	12 months

External Links

•   Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective Multicenter Series: 2-Year Follow-up
•   Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory).
•   WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory.
•   WEB Treatment of Intracranial Aneurysms: Feasibility, Complications, and 1-Month Safety Results with the WEB DL and WEB SL/SLS in the French Observatory.