In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
166 subjects from the premarket cohort, 94 new subjects from 20-30 sites
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.
Followup Visits and Length of Followup
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
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final 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.
Final Effectiveness Findings
Technical implant success was 98%
Study Strengths and 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.