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The WEB-IT Clinical Study

NCT ID: NCT02191618

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2023-06-30

Brief Summary

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The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Detailed Description

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Conditions

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Wide Neck Bifurcation Intracranial Aneurysms Intracranial Aneurysms

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WEB Aneurysm Embolization Device

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Group Type OTHER

WEB

Intervention Type DEVICE

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Interventions

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WEB

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Intervention Type DEVICE

Other Intervention Names

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WEB Aneurysm Embolization Device

Eligibility Criteria

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Inclusion Criteria

* Patient whose age ≥18 and ≤75 years.
* Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
* Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria

* Patient has an IA with characteristics unsuitable for endovascular treatment
* Patient has stroke-in-evolution within the prior 60 days
* Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
* Patient's index IA was previously treated
* Patient is pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Arthur, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist University Hospital, Memphis, TN

David Fiorella, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University, Stony Brook, NY

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Sequent Medical

Aliso Viejo, California, United States

Site Status

Radiology Imaging Associates P.C.

Englewood, Colorado, United States

Site Status

Lyerly Baptist, Inc

Jacksonville, Florida, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Buffalo General Medical Center

Buffalo, New York, United States

Site Status

The Mount Sinai Medical Center

New York, New York, United States

Site Status

Stony Brook University

Stony Brook, New York, United States

Site Status

Carolina NeuroSurgery & Spine Associates, P.A.

Charlotte, North Carolina, United States

Site Status

Riverside Methodist Hospital/ Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status

Ft. Sanders Regional Medical Center

Knoxville, Tennessee, United States

Site Status

Methodist University Hospital

Memphis, Tennessee, United States

Site Status

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Helios Hospital

Erfurt, , Germany

Site Status

National Institute of Neurosciences

Budapest, , Hungary

Site Status

Koru Hospital

Ankara, , Turkey (Türkiye)

Site Status

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Canada Denmark Germany Hungary Turkey (Türkiye)

References

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Arthur AS, Molyneux A, Coon AL, Saatci I, Szikora I, Baltacioglu F, Sultan A, Hoit D, Delgado Almandoz JE, Elijovich L, Cekirge S, Byrne JV, Fiorella D; WEB-IT Study investigators. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16.

Reference Type DERIVED
PMID: 30992395 (View on PubMed)

Fiorella D, Molyneux A, Coon A, Szikora I, Saatci I, Baltacioglu F, Sultan A, Arthur A; WEB-IT Study Investigators. Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT). J Neurointerv Surg. 2017 Dec;9(12):1191-1196. doi: 10.1136/neurintsurg-2016-012841. Epub 2017 Jan 17.

Reference Type DERIVED
PMID: 28096478 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CP13-001

Identifier Type: -

Identifier Source: org_study_id