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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-Training Program

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Application Number P120006 / PAS002
Current Plan Approved 08/28/2013
Study Name OSB Lead-Training Program
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
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 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.

Patients will be categorized into those treated by physicians

¿ who completed fewer than 20 endovascular repairs of AAA with any endovascular graft in the 2 years preceding participation in the Ovation physician training program, and those

¿ who completed 20 or more cases in the preceding 2 years.

Sample Size A total 320 subjects 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 At Implant

¿ Technical failure

¿ Type 1 endoleak

¿ Use of Accessory device

Through 30 days

¿ Serious Adverse Events (SAEs)

¿ 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

Follow-up Visits and Length of Follow-up 30 days

At implant and 30 days

Final Study Results
Number of Patients 320
Number of Sites 49
Follow-up Rate 100% at 30 days
Safety Findings N/A
Effect Findings At Implant

Endpoint results for physicians with fewer than 20 prior endovascular repairs and physicians with 20 or

more prior endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: Technical failure 0% for both physician groups, Type 1 endoleak 0% vs. 0.7% (95% CI for difference: -3.4%, 4.7%), and Use of Accessory devices 0.0% vs.8.9% (95% CI for difference:

2.6%, 15.2%), respectively.

Through 30 days post Implant

The adverse events rates for physician with fewer than 20 endovascular repairs and physicians with 20 or more endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: AAA-related secondary endovascular procedures 0% vs. 1.0%, device-related SAEs 0% vs. 1.3%, and renal events (including acute kidney injury, renal insufficiency, renal failure) 0% vs. 1.7%, respectively. No statistically significant differences were observed between the 2 groups for any adverse event. The rates for thromboembolic events, paralysis/paraparesis, stroke, claudication and ischemic colitis were 0% in both physician groups.

Strengths & Weaknesses The study achieved the target enrollment of 320 patients with 100% follow-up at 30days and a high technical success. Patient enrollment in the physicians with fewer than 20 prior endovascular experience group was low.
Label Changes Labeling change is recommended to reflect the Training Program evaluation data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post- approval study methods (including study objectives, design, population, number of enrolled

sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.

OSB Lead-Training Program Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/05/2013 04/10/2013 Overdue/Received
one year report 10/05/2013 09/19/2013 On Time
18 month report 04/05/2014 04/02/2014 On Time
two year report 10/05/2014 09/23/2014 On Time
three year report 10/05/2015 09/21/2015 On Time
Final Report 03/02/2016 03/02/2016 On Time
revision to final report 10/05/2016 10/05/2016 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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