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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
¿ Workhorse (WH) Trial is a prospective, randomized, controlled, single blind, multicenter, non-inferiority trial
¿ Small Vessel (SV)
is a prospective, single-arm, multi-center sub-study
¿ Human Pharmacokinetics (PK) is a prospective, single-arm, multi-center, international, observational sub-study
Study Population Description
Continued follow-up of the premarket cohorts:
¿ WH - Subjects with a maximum of 2 de novo
lesions ≤ 24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm. PROMUS Element (test) vs. PROMUS (control)
¿ SV - Subjects with a single target lesion ≤28 mm in length in a native coronary artery ≥2.25 mm to <2.50 mm. PROMUS Element (test) vs. TAXUS Express (historical control)
¿ PK - Subjects with a maximum of 2 de novo lesions ≤24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm
Sample Size
¿ WH ¿ 1,532
¿ SV ¿ 94
¿ PK ¿ 20-30
Approximately 85 sites in the US, 50 in Europe,
15 in the IC region, and 10 in Japan
Data Collection
¿ WH ¿ target lesion failure (TLF), MI, or death at 12 months
¿ SV - TLF
at 12 months
¿ PK - whole blood everolimus levels as delivered by the PROMUS Element stent.
Followup Visits and Length of Followup
Through 5 years post-procedure
12 months, 18 months, 2 years, 3 years, 4 years, and 5
