Clinical trial NCT02191618: The WEB-IT Clinical Study
Official title: The WEB® Intrasaccular Therapy Study (WEB-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wide Neck Bifurcation Intracranial Aneurysms
Intracranial Aneurysms
Keywords: Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.
timeFrame: 12 months
measure: Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Aliso Viejo
country: United States
facility: Sequent Medical
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates P.C.
state: Colorado
city: Jacksonville
country: United States
facility: Lyerly Baptist, Inc
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: Carolina NeuroSurgery & Spine Associates, P.A.
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital/ Ohio Health Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Knoxville
country: United States
facility: Ft. Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Erfurt
country: Germany
facility: Helios Hospital
city: Budapest
country: Hungary
facility: National Institute of Neurosciences
city: Ankara
country: Turkey
facility: Koru Hospital
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine Pendik Training and Research Hospital
Study officials:
affiliation: Methodist University Hospital, Memphis, TN
name: Adam Arthur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University, Stony Brook, NY
name: David Fiorella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.