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.
The study is a prospective, multi-center, non-randomized, single arm.
Study Population Description
Patients with neurological symptoms and > 70% stenosis of the common or internal carotid artery
by ultrasound or > 50% stenosis of the common or internal carotid artery by angiogram OR patients without neurological symptoms and > 70% stenosis of the common or internal carotid artery by ultrasound or > 60% stenosis of the common or internal carotid artery by angiogram.
The trial will enroll a minimum of 1,200 subjects (336 symptomatic and 864 asymptomatic subjects)
at up to 350 sites in the United Sates.
The overall trial sample size was determined based on the secondary endpoint of peri- procedural DS by symptomatic status and its comparison with the respective PG (Symptomatic subjects: n= 336, accounting for 22 subject lost to follow-up; Asymptomatic subjects: n= 864 subjects, accounting for 58 subject lost to follow-up).
Primary Endpoint: A composite rate of peri-procedural (within 30 days of the procedure) DS, plus
ipsilateral stroke between day 31 and 1 year (365 days)
1. Composite of peri-procedural DS by symptomatic status
2. Ipsilateral stroke at 2 and 3 years
3. Composite of peri-procedural DS plus ipsilateral stroke at 1, 2, and 3 years for octogenarians
4. Annual rate of clinically driven target lesion revascularization (TLR) through 3 years
Followup Visits and Length of Followup
24-hours post-procedure period, 30-days, 1-year and annually for a total of 3 years