NCT03844334

Brief Summary

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

3.4 years

First QC Date

February 12, 2019

Last Update Submit

January 22, 2024

Conditions

Brain Aneurysm

Outcome Measures

Primary Outcomes (2)

  • Aneurysm occlusion

    Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. * class I: complete obliteration * class II: residual neck * class III: residual aneurysm

    12 months

  • Incidence of major stroke or neurological deaths

    The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

    12months

Interventions

WEB Aneurysm Embolization SystemDEVICE

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this study

You may qualify if:

  • Subject must be ≥ 18 years of age and ≤80 years of age
  • Subject must have an intracranial aneurysm (IA),
  • Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
  • For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III

You may not qualify if:

  • Subject has an IA with characteristics unsuitable for endovascular treatment
  • Subject's index IA was previously treated
  • Subject has stroke-in-evolution within the prior 30 days
  • An additional aneurysm must be treated during the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Universitätsklinikum Knappschaftskrankenhaus

Bochum, 44892, Germany

Location

National Institute of Clinical Neurosciences

Budapest, 1145, Hungary

Location

Related Publications (1)

  • Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Mohlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, Cognard C. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms. J Neurointerv Surg. 2024 Nov 22;16(12):1299-1306. doi: 10.1136/jnis-2023-020866.

    PMID: 37914392DERIVED

Related Links

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 18, 2019

Study Start

March 21, 2019

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

FR(2)DE(1)HU(1)