The WEB-IT Clinical Study (WEB-IT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc
ClinicalTrials.gov Identifier:
NCT02191618
First received: July 14, 2014
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
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 Intervention
Wide Neck Bifurcation Intracranial Aneurysms
Intracranial Aneurysms
Device: WEB

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)

Resource links provided by NLM:


Further study details as provided by Sequent Medical, Inc:

Primary Outcome Measures:
  • Primary Safety Outcome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 150
Study Start Date: August 2014
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT02191618     History of Changes
Other Study ID Numbers: CP13-001 
Study First Received: July 14, 2014
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 29, 2016