Back to resultsPost Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device (WEB PAS)
Primary Purpose
Wide Neck Bifurcation Intracranial Aneurysms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WEB
Sponsored by
About this trial
This is an interventional treatment trial for Wide Neck Bifurcation Intracranial Aneurysms focused on measuring Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders
Eligibility Criteria
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 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 other intracranial hemorrhage within 90 days
- Patient index IA was previously treated
- Patient is pregnant
Sites / Locations
- Albany Medical CenterRecruiting
- West Virginia UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
WEB Aneurysm Embolization Device
Arm Description
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.
Outcomes
Primary Outcome Measures
Key Effectiveness Outcome
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04839705
First Posted
April 7, 2021
Last Updated
January 23, 2023
Sponsor
Microvention-Terumo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04839705
Brief Title
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Acronym
WEB PAS
Official Title
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide Neck Bifurcation Intracranial Aneurysms
Keywords
Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WEB Aneurysm Embolization Device
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WEB
Intervention Description
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 Information:
Title
Key Effectiveness Outcome
Description
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Time Frame
12 Months
Title
Key Safety Outcome
Description
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
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 other intracranial hemorrhage within 90 days
Patient index IA was previously treated
Patient is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Arthur, MD
Organizational Affiliation
Methodist University Hospital, Memphis TN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD
Organizational Affiliation
Stony Brook University, Stony Brook NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Paller
Phone
518-262-5368
Email
pallera@amc.edu
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Domico
Phone
304-293-7012
Email
jennifer.domico@wvumedicine.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
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