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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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ODE Lead-ANSWER Clinical Study


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General
Study Status Progress Inadequate
Application Number H160002 / PAS001
Study Name ODE Lead-ANSWER Clinical Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Adjunctive Neurovascular Support for Wide-Neck Aneurysm and Reconstruction (ANSWER) (Revision E): Post-Approval Study of a 365 day follow as part of the approved ANSWER study as a condition of approval per the FDA’s 19 June 2017 HDE approval letter. The study endpoints evaluated at 1 year follow-up are neurological death or stroke, technical success, rate of aneurysm occlusion, device movement or migration, stenosis, rate of incidence of new neurological deficits, and complication rate (neurological and non-neurological).
The study endpoints identified above were reviewed and approved in the ANSWER Study Protocol under IDE # G130268. The zero to 180-day clinical data has been submitted, reviewed and approved under HDE # H160002. Per the HDE approval letter the ANSWER Study Protocol would serve as Pulsar’s Post-Approval Study Protocol
Study Population Description Subjects who met the protocol entry criteria with at least one bifurcation intracranial aneurysm that is acceptable for minimally invasive treatment who were enrolled under the ANSWER study IDE G130268
Sample Size 34 subjects
Data Collection This post-approval study progress report will provide a brief summary of the results including the 1-year follow-up.

Primary Endpoints:

Safety – neurological death or major ipsilateral stroke in downstream territory to 1 year post-procedure

Occlusion – rate of aneurysm occlusion at day zero, 180 days, and 365 days using the Raymond Scale

Technical success – device placement success and ability to retain coils within aneurysm

Additional Evaluations

Incidence of new neurological deficits

Complication rate (neurological and non-neurological)

Rate of occlusion at 365 days

Device movement or migration

Stenosis at implant site
Follow-up Visits and Length of Follow-up 1 year post implantation


ODE Lead-ANSWER Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/26/2018 01/12/2018 On Time
one year report 06/19/2018 06/19/2018 On Time
18 month report 12/18/2018    
two year report 06/19/2019    
three year report 06/18/2020    
four year report 06/18/2021    
five year report 06/18/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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