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
A non-randomized, multicenter, prospective, single- arm study.
Study Population Description
Patients enrolled in the pivotal STROLL study who received the S.M.A.R.T. Nitinol Self-Expandable Stent. There
is no pre-specified control group.
Sample Size
39 sites in the United States. A total of evaluable subjects at 3 year follow-up.
Data Collection
Primary safety endpoint: A composite of all-cause death, amputation and target lesion revascularization (TLR) at
3 years.
Secondary Endpoints to be assessed at 2 and 3 years: (1) individual components of the composite safety endpoint including death, amputation and TLR, (2) Major adverse events (MAE) defined as: death, limb ischemia/amputation of target limb, TLR, or significant embolic events causing organ damage, (3) Stent fracture rate assessed by x-ray, (4) Clinically driven TLR, and target vessel revascularization (TVR), (5) Patency of the target vessel assessed by duplex ultrasound, (6) Limb ischemia assessed by Rutherford/Becker classification, and (7) Ankle brachial index.
Followup Visits and Length of Followup
No new enrollments are planned for the post-approval study.
