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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 Adequate
Application Number H160002 / PAS001
Study Name ODE Lead-ANSWER Clinical Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is a prospective, multi-center, single-arm, non-randomized study. The objective of this study is to assess the safety and probable benefit of the PulseRider in the minimally invasive endovascular treatment of wide-neck basilar or carotid terminus bifurcation intracranial aneurysms. It is continued follow-up of premarket cohorts up to 365 days without any new enrollment.
Study Population Description Patients who meet the protocol inclusion/exclusion criteria with at least one bifurcation intracranial aneurysm that is acceptable for minimally invasive treatment.
Sample Size Up to 35 patients to yield at least 30 evaluable patients
Data Collection Primary Endpoints:

Safety: Neurological death and major ipsilateral or downstream stroke to 180-days post-procedure. Major stroke is defined as a stroke, which is present after seven days and increases the National Institute of Health Stroke Scale (NIHSS) of the patient by greater than or equal to 4.

• Technical Success: Device placement success and ability to retain coils within the aneurysm (as judged by the treating physician at the time of the procedure). Core lab will review images at a later time.

• Probable Benefit: Rate of aneurysm occlusion at day zero (0) based on Raymond I

• Probable Benefit: Rate of aneurysm occlusion at 180-days follow-up as defined using Raymond I and II.



Additional Evaluations to 180-Days and 365-Days Follow-Up:

• Rate of aneurysm occlusion at 365 days

• Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2 mm by conventional catheter angiography (180 days) and by conventional catheter angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA) (365 days)

• Stenosis defined as > 50% at implant site by conventional catheter angiography at 180 days and MR angiography or conventional catheter angiography or CTA at 365 days

• Rate of incidence of new neurological deficits

• Complication rate (neurological and non-neurological)

Follow-up Visits and Length of Follow-up 365 days


ODE Lead-ANSWER Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/18/2017    
one year report 06/19/2018    
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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