Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Description

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.

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

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Study Overview

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Study Details

Study overview

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.

Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Condition
Wide Neck Bifurcation Intracranial Aneurysms
Intervention / Treatment

-

Contacts and Locations

Hollywood

Memorial Health Systems, Hollywood, Florida, United States, 33021

Orlando

Orlando Health Neuroscience Institute, Orlando, Florida, United States, 32806

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Kansas City

University of Kansas Health System, Kansas City, Kansas, United States, 66160

Lexington

Baptist Health Systems, Lexington, Kentucky, United States, 40503

Lexington

University of Kentucky, Department of Neurosurgery, Lexington, Kentucky, United States, 40536

Louisville

Norton Healthcare, Louisville, Kentucky, United States, 40241

Shreveport

LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States, 71103

Baltimore

University of Maryland, Baltimore, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Microvention-Terumo, Inc.,

Adam Arthur, MD, PRINCIPAL_INVESTIGATOR, Methodist University Hospital, Memphis TN

David Fiorella, MD, PRINCIPAL_INVESTIGATOR, Stony Brook University, Stony Brook NY

Study Record Dates

2029-12