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
Approximately 1125 subjects were originally planned to be enrolled in the study; however, the study
was expanded to 3690 subjects. Subjects in the SPIRIT IV clinical study were randomized 2:1, with 2460 subjects to receive XIENCE V and 1230 subjects to receive TAXUS.
Study Population Description
This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease
due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. The study population consisted of the long term follow-up of pateints enrolled in the SPIRIT FIRST, SPIRIT II, SPIRIT III RCT, SPIRIT III 4.0 and SPIRIT IV trials.
Sample Size
SPIRIT FIRST: 60 patients, 9 sites, SPIRIT II: 300 patients, no site maximum specified, SPIRIT
III RCT: 1002 patients, 65 sites, SPIRIT III 4.0: 80 patients, 30 sites. SPIRIT IV: 3690 patients, 66 sites
Data Collection
The primary endpoint of the SPIRIT FIRST clinical study was in-stent LL at 180 days
on the per-treatment evaluable population. The primary endpoint of the SPIRIT II trial was in-stent LL at 180 days. The primary endpoint of the SPIRIT III RCT was in-segment LL at 240 days and the major secondary endpoint was ischemia-driven target vessel failuer at 270 days. The primary endpoint of the SPIRIT III 4.0 mm trial was in-segment LL at 240 days. The primary endpoint of the SPIRIT IV trial was target lesion failure at 1 year.
Followup Visits and Length of Followup
SPIRIT FIRST: Patients were evaluated at 30, 180, 270 days and 1, 2, and 3
years following the index procedure. Angiography and IVUS in all patients were performed at 180 days and 1 year post index procedure.; SPIRIT II: Patients were evaluated at 30, 180, 270 days and 1, 2 and 3 years following the index procedure. Angiography in all patients and IVUS on a pre-specified subset of patients (N=152) was performed at 180 days post index procedure. Additionally, 2-year angiography and IVUS was performed in a subset of patients (N=152).; SPIRIT III RCT: Subjects were evaluated at 30, 180, 240, 270 days, one year, and two years following the index procedure. Further clinical observations will be performed at 3 years for all subjects. Angiography was to be performed on all subjects in group A and group B at 240-day follow-up.; SPIRIT III: Subjects were evaluated at 30, 180, 240, 270 days, and one and two years following the index procedure. Further clinical observations will be performed per protocol in newly enrolled subjects and at 3 years for all subjects. Angiography was to be performed on all subjects at their 240-day follow-up. Target enrollment remains 80 subjects
