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History of Changes for Study: NCT02191618
The WEB-IT Clinical Study (WEB-IT)
Latest version (submitted April 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 15, 2014 None (earliest Version on record)
2 August 25, 2014 Contacts/Locations and Study Status
3 September 18, 2014 Contacts/Locations and Study Status
4 October 22, 2014 Recruitment Status, Contacts/Locations and Study Status
5 December 3, 2014 Contacts/Locations and Study Status
6 December 31, 2014 Contacts/Locations and Study Status
7 January 6, 2015 Study Status and Contacts/Locations
8 January 16, 2015 Contacts/Locations and Study Status
9 March 24, 2015 Contacts/Locations and Study Status
10 May 4, 2015 Study Status and Contacts/Locations
11 May 26, 2015 Contacts/Locations and Study Status
12 June 8, 2015 Contacts/Locations and Study Status
13 June 10, 2015 Contacts/Locations and Study Status
14 July 7, 2015 Study Status, Contacts/Locations and Study Design
15 August 13, 2015 Study Status and Contacts/Locations
16 October 6, 2015 Study Status and Contacts/Locations
17 November 19, 2015 Contacts/Locations and Study Status
18 December 10, 2015 Contacts/Locations and Study Status
19 January 27, 2016 Contacts/Locations and Study Status
20 March 8, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
21 September 26, 2016 Study Status
22 February 8, 2018 Study Status
23 October 9, 2018 Study Status
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Results Submission Events
24 April 13, 2020 Study Status, Outcome Measures, More Information, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
25 April 13, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT02191618
Submitted Date:  July 15, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: CP13-001
Brief Title: The WEB-IT Clinical Study (WEB-IT)
Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Not yet recruiting
Study Start: August 2014
Primary Completion: December 2020 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: July 14, 2014
First Submitted that
Met QC Criteria:
July 15, 2014
First Posted: July 16, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 15, 2014
Last Update Posted: July 16, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sequent Medical, Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Wide Neck Bifurcation Intracranial Aneurysms
Intracranial Aneurysms
Keywords: Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 139 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • WEB Aneurysm Embolization Device
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Adam Arthur, MD
Principal Investigator
Baptist Hospital, Memphis, TN
David Fiorella, MD
Principal Investigator
Stony Brook University
Locations: United States, California
Sequent Medical, Inc.
Aliso Viejo, California, United States, 92656
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
United States, Tennessee
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, United States, 38120
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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