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 an observational cohort of registry patients, chosen from a minimum of 15 multi-national
investigative sites, with a maximum number of 25 patients enrolled at any one site.
Study Population Description
Consecutive patients who meet the inclusion criteria and who are willing to participate will be
enrolled in the study. For inclusion in the study, patients must have a descending thoracic aortic aneurysm of at least 5 cm diameter, or with a history of growth of at least 0.5 cm per year, or degenerative or atherosclerotic ulcer of at least 10 mm in depth and 20 mm in diameter, AND patient must not meet any of the general, medical or anatomical exclusion criteria.
300 subjects, up to 50 sites Factoring in a 10% dropout rate, that adds up
to 300. This will include 160 endovascular treatment patients from the pivotal clinical trial, plus an additional 125 endovascular patients, which allows for 12 patients lost to follow-up.
Aneurysm-related mortality is the primary endpoint. Additional endpoints to be assessed include device performance (change
in aneurysm size, endoleaks, migration, device integrity, and secondary interventions) and morbidity.
Followup Visits and Length of Followup
Patients will be followed for a total of five years. Termination of follow-up will occur
30 days following explant, and upon patient withdrawal, death or closure of pre-market study.