WEB French Observatory of the WEB Aneurysm Embolization System

January 25, 2023 updated by: Microvention-Terumo, Inc.

WEB French Observatory

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU Pellegrin
      • Caen, France, 14033
        • CHU côte de Nacre
      • Clichy, France, 92110
        • CHU Beaujon
      • Lyon, France, 69500
        • Hôpital Neurologique Pierre Wertheimer
      • Nantes, France, 44093
        • Hôpital Nord Laennec
      • Potiers, France, 86021
        • CHU La Milétrie
      • Reims, France, 51092
        • CHU Reims - Hôpital Maison-Blanche
      • Rennes, France, 35033
        • CHU Pontchailloux
      • Toulouse, France, 31059
        • CHU Purpan
      • Tours, France, 37000
        • CHU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
WEB Aneurysm Embolization System
Subjects aged ≥ 18 years, but ≤ 75 years requiring treatment for intracranial aneurysms.
Device: WEB Aneurysm Embolization System
WEB Aneurysm Embolization System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of aneurysm occlusion
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence/recanalization rate
Time Frame: 12 months
Rate of aneurysm recanalization
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Modified Raymond Scale
Time Frame: 12 months
12 months
Percentage occlusion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Laurent Pierot, MD PhD, CHU Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12001 (DAIDS-ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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