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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PAS2 - WEB-IT Study


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General
Study Status Completed
Application Number /
Requirement Number		 P170032 / PAS002
Date Original Protocol Accepted 12/31/2018
Date Current Protocol Accepted  
Study Name PAS2 - WEB-IT Study
Device Name Woven EndoBridge (WEB) Aneurysm Embolization System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives A prospective, single-arm, multicenter, international interventional cohort.
Study Population The study population is comprised of subjects with intracranial wide-neck aneurysms located at arterial bifurcations.
Sample Size The sample size is 200 patients.
Key Study Endpoints Study endpoints include adequate aneurysm occlusion, death, major stroke and additional neurological deficit.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 150 subjects enrolled in the study at the time of database extraction, and 123 subjects remaining in the study and being followed for 5 years.
Actual Number of Sites Enrolled 21 U.S. sites and 6 OUS sites
Patient Follow-up Rate clinical follow up rate >90% for all scheduled visits. The 5-yr cumulative Imaging follow-up is 55%.
Final Safety Findings Twenty-seven (27) aneurysm retreatments occurred during this study involving 23 subjects.
There were no unanticipated adverse events (UADEs). There have been no events of re-bleed of previously ruptured treated index aneurysms or new bleeds from unruptured treated index aneurysms for the study.
There were no reported device- or procedure-related serious adverse events later than the 30 day follow up visit.
Between 1 year and 5 year, there have been twelve (12) events classified as AEs of Special Interest, all adjudicated as unrelated to the WEB device.
Final Effect Findings Primary effectiveness endpoint has been evaluated in the 12-month IDE study and is not the focus of this PAS review.
Study Strengths & Weaknesses
Strength: A prospective and long-term study with clinical follow-up rate for ITT population above 90%.

Weaknesses: Single arm study not controlling for confounding factors. Imaging follow-up rate is low.
Recommendations for Labeling Changes Recommend Labeling update to include long-term study results from the PAS.


PAS2 - WEB-IT Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/01/2019 06/27/2019 On Time
one year report 12/31/2019 12/26/2019 On Time
18 month report 06/30/2020 06/30/2020 On Time
two year report 12/30/2020 12/17/2020 On Time
3 year report 12/30/2021 12/21/2021 On Time
final report 12/30/2022 06/09/2022 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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