Clinical trial NCT04839705: Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Official title: Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wide Neck Bifurcation Intracranial Aneurysms
Keywords: Aneurysm
Intracranial Arterial Disease
Cerebrovascular Disorders
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.


Eligibility criteria: Key Inclusion Criteria:

* Patient must be ≥ 18 at the time of screening
* Patient must have a single ruptured or unruptured IA requiring treatment
* Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures

Key Exclusion Criteria:

* Patient has an IA with characteristics unsuitable for endovascular treatment
* Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
* Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
* Patient index IA was previously treated
* Patient is pregnant

Primary outcomes:
measure: Key Effectiveness Outcome
timeFrame: 12 Months
measure: Key Safety Outcome
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Health Systems
state: Florida
city: Orlando
country: United States
facility: Orlando Health Neuroscience Institute
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center Neuroscience Institute
state: Hawaii
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Systems
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky, Department of Neurosurgery
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Brigham Incorporated
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Health
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital Allina Health
state: Minnesota
city: St Louis
country: United States
facility: The Washington University
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Manhasset
country: United States
facility: Northshore University Hospital/Northwell Health
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital d/b/a ProMedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
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: