RECRUITING

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

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Conditions

Wide Neck Bifurcation Intracranial AneurysmsAneurysmIntracranial Arterial DiseaseCerebrovascular Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-24
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04839705

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be ≥ 18 at the time of screening
  2. * Patient must have a single ruptured or unruptured IA requiring treatment
  3. * Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
  1. * Patient has an IA with characteristics unsuitable for endovascular treatment
  2. * 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
  3. * Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
  4. * Patient index IA was previously treated
  5. * Patient is pregnant

Contacts and Locations

Study Contact

Amy Bowles
CONTACT
714-482-8074
amy.bowles@microvention.com

Principal Investigator

Adam Arthur, MD
PRINCIPAL_INVESTIGATOR
Methodist University Hospital, Memphis TN
David Fiorella, MD
PRINCIPAL_INVESTIGATOR
Stony Brook University, Stony Brook NY

Study Locations (Sites)

Memorial Health Systems
Hollywood, Florida, 33021
United States
Orlando Health Neuroscience Institute
Orlando, Florida, 32806
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Kansas Health System
Kansas City, Kansas, 66160
United States
Baptist Health Systems
Lexington, Kentucky, 40503
United States
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky, 40536
United States
Norton Healthcare
Louisville, Kentucky, 40241
United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Massachusetts General Brigham Incorporated
Boston, Massachusetts, 02114
United States
UMass Memorial Health
Worcester, Massachusetts, 01655
United States
Abbott Northwestern Hospital Allina Health
Minneapolis, Minnesota, 55407
United States
The Washington University
Saint Louis, Missouri, 63110
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
University of Buffalo
Buffalo, New York, 14203
United States
Northshore University Hospital/Northwell Health
Manhasset, New York, 11030
United States
SUNY Stony Brook
Stony Brook, New York, 11794
United States
Ohio State University
Columbus, Ohio, 43210
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo, Ohio, 43606
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Semmes Murphey
Memphis, Tennessee, 38120
United States
West Virginia University
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-24
Study Completion Date2029-12

Study Record Updates

Study Start Date2022-08-24
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Aneurysm
  • Intracranial Arterial Disease
  • Cerebrovascular Disorders

Additional Relevant MeSH Terms

  • Wide Neck Bifurcation Intracranial Aneurysms