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The WEB-IT Clinical Study (WEB-IT)

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ClinicalTrials.gov Identifier: NCT02191618
Recruitment Status : Active, not recruiting
First Posted : July 16, 2014
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc

Brief Summary:
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Condition or disease Intervention/treatment Phase
Wide Neck Bifurcation Intracranial Aneurysms Intracranial Aneurysms Device: WEB Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

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



Primary Outcome Measures :
  1. Primary Safety Outcome [ Time Frame: 12 months ]
    The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient whose age ≥18 and ≤75 years.
  • Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
  • Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  • Patient has an IA with characteristics unsuitable for endovascular treatment
  • Patient has stroke-in-evolution within the prior 60 days
  • Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
  • Patient's index IA was previously treated
  • Patient is pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191618


  Show 31 Study Locations
Sponsors and Collaborators
Sequent Medical, Inc
Investigators
Principal Investigator: Adam Arthur, MD Methodist University Hospital, Memphis, TN
Principal Investigator: David Fiorella, MD Stony Brook University, Stony Brook, NY

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT02191618     History of Changes
Other Study ID Numbers: CP13-001
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Sequent Medical, Inc:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases