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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Long Term Follow-up Study


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General
Application Number P120006 / PAS001
Current Plan Approved 06/21/2013
Study Name OSB Lead-Long Term Follow-up Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, consecutively enrolling, single-arm, non-randomized, multi-

center study

Study Population Description Patients with an abdominal aortic aneurysm with vascular morphology

suitable for endovascular repair with the Ovation/Ovation Prime Abdominal

Stent Graft System. Eligible patients must have met or must meet all of the inclusion criteria and none of the exclusion criteria.

Comparator: Performance Goal of 92%

Sample Size A total 320 subjects yielding at least 192 evaluable subjects at 5 years.

Comprises of 161 pivotal cohort subjects, all continued access subjects, all subjects from the HDE PAS and at least 59 de novo subjects enrolled from

a minimum of 15 U.S. sites.

Data Collection Primary Endpoint: Aneurysm-related mortality at 5 years



Secondary Endpoints:

¿ Serious Adverse Events (SAEs) assessed through 30 days, 12 months then annually until 5 years post initial implant.



¿ Mortality (AAA-related and all-cause)

¿ Device Patency

¿ Conversion to open surgical repair

¿ Endoleak

¿ AAA enlargement

¿ Stent Graft Migration

¿ Device integrity

¿ Secondary endovascular procedures

¿ Aneurysm rupture

All endpoints assessed at 30 days and 12 months, then annually thereafter

through 5 years post initial implant.

Follow-up Visits and Length of Follow-up 5 years

30 days, 12 months and annually thereafter.



OSB Lead-Long Term Follow-up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/05/2013 04/04/2013 On Time
one year report 10/05/2013 09/26/2013 On Time
18 month report 04/05/2014 04/01/2014 On Time
two year report 10/05/2014 09/30/2014 On Time
three year report 10/05/2015 09/25/2015 On Time
four year report 10/04/2016    
five year report 10/04/2017    


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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