Recruiting

Intracranial Aneurysm

Sponsor:

Microvention-Terumo, Inc.

Code:

NCT04839705

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WEB

Study Details

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.

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

Study ID

NCT04839705

Start date

Aug 24, 2022

Status verified date

Nov, 2026

Completion date

May 7, 2031

Anticipated

Primary completion date

May 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 IRB-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 any other intracranial hemorrhage within 90 days
  • Patient's index IA was previously treated
  • Patient is pregnant

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: WEB Aneurysm Embolization Device

WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Interventions

WEB

Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Other Names:

• WEB Aneurysm Embolization Device

Primary outcome measure

  • Key Effectiveness Outcome [ Time Frame: 12 Months ]
  • Key Safety Outcome [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Robert Gash

908-914-1045robert.gash@terumo.com

Locations

Memorial Health Systems

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Piret Baldwin

954-558-1194pibaldwin@mhs.net

Principal Investigator:

Brijesh Mehta, MD

Orlando Health Neuroscience Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Thomas Melendez

407-687-6678Thomas.Melendez@orlandohealth.com

Principal Investigator:

Jay Vachhani, MD

The Queen's Medical Center Neuroscience Institute

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Kelly Diedrich

808-691-4428KDiedrich@Queens.org

Principal Investigator:

Yi Zhang, MD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Heena Olalde

319-356-8326heena-olalde@uiowa.edu

Principal Investigator:

Edgar Samaniego, MD

University of Kansas Health System

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Max Hardenbrook

913-588-6191mhardenbrook@kumc.edu

Principal Investigator:

Koji Ebersole, MD

Baptist Health Systems

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Candice Brunton

502-708-9791Candice.Brunton@bhsi.com

Principal Investigator:

Richard Paulsen, MD

University of Kentucky, Department of Neurosurgery

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Rachel Norris

859-218-1644rachel.norris@uky.edu

Principal Investigator:

David Dornbos, MD

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Trina DeForrest

502-446-8991Trina.Deforrest@nortonhealthcare.org

Principal Investigator:

Tom Yao, MD

LSU Health Sciences Center at Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Annabeth Piro

318-675-4892annabeth.piro@lsuhs.edu

Principal Investigator:

Hugo Cuellar-Saenz, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rachael Eddowes

reddowe1@jh.edu

Principal Investigator:

Justin Caplan, MD

Massachusetts General Brigham Incorporated

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Shayna Hollander

617-643-5547sdhollander@mgh.harvard.edu

Principal Investigator:

Christopher Stapleton, MD

UMass Memorial Health

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Noelle Bodkin

508-856-2067Noelle.bodkin@umassmed.edu

Principal Investigator:

Anna Kuhn, MD

Abbott Northwestern Hospital Allina Health

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Nimco Essa

614-806-5484nimco.essa@allina.com

Principal Investigator:

Yasha Kayan, MD

The Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ramie Heo

314-747-4569heor@wustl.edu

Principal Investigator:

Joshua Osbun, MD

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Julia Zajaceskowski

518-262-5868ahmedt4@amc.edu

Principal Investigator:

Alexandra Paul, MD

University of Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Eric Miller

814-403-6855emiller@ubns.com

Principal Investigator:

Adnan Siddiqui, MD

Northshore University Hospital/Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Stanislav Ostrovski

516-423-1682sostrovskiy1@northwell.edu

Principal Investigator:

Timothy White, MD

SUNY Stony Brook

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Dawn Madigan

631-444-8121Dawn.Madigan@stonybrookmedicine.edu

Principal Investigator:

David Fiorella, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Lavinia Williams

718-502-0552lavwilliam@montefiore.org

Principal Investigator:

David Altschul, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Edouard Belizaire

614-769-2995Edouard.belizaire@osumc.edu

Principal Investigator:

Patrick Youssef, MD

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Marissa Mosher

614-566-1260marissa.mosher@ohiohealth.com

Principal Investigator:

Ronald Budzik, MD

The Toledo Hospital d/b/a ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Jennifer Dura

419-291-3306Jennifer.dura@promedica.org

Principal Investigator:

Mouhammad Jumaa, MD

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Michael Omini

785-979-6704michael-omini@ouhsc.edu

Principal Investigator:

Hakeem Shakir, MD

University of Pennsylvania Health Systems

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Inhye Hwang

801-831-1044inhye.hwang@pennmedicine.upenn.edu

Principal Investigator:

Jan-Karl Burkhardt, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sha'Mere Herder

215-503-9110Shamere.Herder@jefferson.edu

Principal Investigator:

Pascal Jabbour, MD

Semmes Murphey

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Amira King

662-804-9800aking@semmes-murphey.com

Principal Investigator:

Daniel Hoit, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Jennifer Domico

304-293-7012jennifer.domico@wvumedicine.org

Principal Investigator:

Sohyun Boo, MD

More Information

Sponsor

Microvention-Terumo, Inc.

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Aneurysm
  • Intracranial Arterial Disease
  • Cerebrovascular Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Microvention-Terumo, Inc. on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.