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

Last updated: September 12, 2024
Sponsor: Microvention-Terumo, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

WEB

Clinical Study ID

NCT04839705
CL11010-001
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 toinitiation of any study procedures

Exclusion

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 hasexhibited ischemic symptoms such as transient ischemic attacks, minor strokes, orstroke-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

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: WEB
Phase:
Study Start date:
August 24, 2022
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Memorial Health Systems

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Orlando Health Neuroscience Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Health System

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Baptist Health Systems

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • University of Kentucky, Department of Neurosurgery

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Norton Healthcare

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Massachusetts General Brigham Incorporated

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • UMass Memorial Health

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Abbott Northwestern Hospital Allina Health

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • The Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • University of Buffalo

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Northshore University Hospital/Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • SUNY Stony Brook

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • The Toledo Hospital d/b/a ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania Health Systems

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Semmes Murphey

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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