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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-Vitality Trial


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General
Application Number P070027 / PAS001
Current Plan Approved 11/05/2008
Study Name OSB Lead-Vitality Trial
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 This is a prospective, one armed, non-randomized, observational, multi-site study. The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and

effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.This study incorporates the Test Group from the Talent Abdominal PMA (eLPS cohort), consisting of 166 subjects. In addition, 94 new subjects will be prospectively enrolled to compliment the PMA subjects. All subjects are followed for a total of 5 years following initial implantation.
Study Population Description Subjects will include patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved indications for use. The stent graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having: 1) Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) - A proximal aortic neck length of > 10 mm; 3) Proximal aortic neck angulation < 60 ; 4) Distal iliac artery fixation length of > 15 mm; 5) An aortic neck diameter of 18-32 mm and iliac artery diameters of 8-22 mm; and 6) Vessel morphology suitable for endovascular repair.
Sample Size 166 subjects from the premarket cohort, 94 new subjects from 20-30 sites
Data Collection Primary endpoint: Freedom from aneurysm-related mortality at 5 years. Death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the abdominal aortic aneurysm. If a death occurred within 30 days of any procedure intended to treat the abdominal aortic aneurysm, then it is presumed to be aneurysm related.
Follow-up Visits and Length of Follow-up Subjects are followed at 1-month, 6-months, 12-months, 24 months, 36 months, 48 months, and 60 months post-implant. Total duration of follow-up is 5 years.
Final Study Results
Interim Safety Information The freedom from aneurysm-related mortality at 5 years appears to be well above the objective performance criteria of 91%
Number of Patients 260
Number of Sites 20
Follow-up Rate 72.7%
Safety Findings There were three aneurysm-related deaths in the first 30 days, two more in year one, one in year two, and one in year three. The Kaplan-Meier estimate for freedom from AAA-related mortality was 97.0% at five years (lower 95% limit of confidence interval at five years was 95.0%). There were very few aneurysm ruptures, conversions to open surgery, problems with stent graft patency, integrity, or migration, Type I and III endoleaks have remained at less than 3% annually combined.
Effect Findings Technical implant success was 98%
Strengths & Weaknesses Although mortality, aneurysm-related mortality, and secondary procedures were found to be higher than that in males, and although the major adverse event rates were found to be higher in non-whites than in whites, the sample sizes for females (n = 33) and non-whites (n = 19) were far too small for adequate statistical comparisons of these variables.
Label Changes No


OSB Lead-Vitality Trial Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/15/2008 10/15/2008 On Time
12 month report 05/11/2009 05/11/2009 On Time
18 month report 10/15/2009 10/14/2009 On Time
2 year report 04/08/2010 04/08/2010 On Time
3 year report 04/15/2011 04/11/2011 On Time
4 year report 04/15/2012 04/06/2012 On Time
5 year report 04/15/2013 04/05/2013 On Time
6 year report 04/15/2014 04/07/2014 On Time
7 year report 04/15/2015 04/03/2015 On Time
Final Report 04/15/2016 10/08/2015 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
20993-0002

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

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