Post-Approval Studies (PAS) Database

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.

Learn more...

PAS2 - WEB-IT Study

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
Clinical Trial Number(s)	NCT03207087
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 yrs < 22 yrs, Adult: At least 22 yrs
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

---

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background