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.
Prospective, open-label, multi-center cohort study
Study Population Description
Newly Enrolled Post-approval Study Population Consecutive patients who are eligible to receive a ION Stent as
indicated by the product labeling will be evaluated for enrollment into the study ION US Post Approval Study (PAS). Only those participants in the PAS cohort that are identified as PERSEUS-like will contribute towards the primary endpoint and the main secondary endpoint. Data from the entire PAS cohort will be used in the additional secondary endpoints.
PERSEUS-like has been defined as all patients without acute MI, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, multivessel stenting, Reference Vessel Diameter (RVD) < 2.25 mm, RVD > 4.00 mm, lesion length > 28 mm, cardiogenic shock, acute or chronic renal function (serum creatinine > 3.0mg/dl or patient on dialysis).
PERSEUS-like TAXUS Element Population The new PERSEUS-like ION US PAS cohort participants will be combined with the following extant cohorts of the TAXUS Element (ION) patients from the TAXUS PERSEUS Workhorse (WH) and Small Vessel (SV) Clinical Trials and the TAXUS Element PERSEUS-like patients from the TAXUS Element EU COA study (TE-Prove). This will constitute the PERSEUS-like TAXUS Element total study population evaluated under the Primary Endpoint, Main Secondary Endpoint, and Diabetic Subset analysis.
The ION US PAS uses data from their newly enrolled subjects and other ION studies. The newly
enrolled ION PAS US cohort will be 1,115 subjects enrolled at up to 65 U.S. sites.
The ION population is expected to be approximately 1,901 subjects with 12- month follow-up. This includes the 1,140 ION subjects from the TAXUS PERSEUS WH and SV Clinical Trials with 12-month follow-up, 360 ION PERSEUS-like subjects from the TAXUS Element EU COA study (TE-Prove) and approximately 401 ION PERSEUS-like subjects from the ION US Post- Approval Study.
To allow for approximately 3.5% attrition per year, 2,012 PERSEUS-like subjects will be required to provide at least 1,660 PERSEUS-like subjects through 3-year follow-up. This will include 1,166 subjects enrolled in the TAXUS PERSEUS WH and SV Clinical Trials, 400 ION PERSEUS-like subjects from the TAXUS Element EU COA study (TEProve) and approximately 446 ION PERSEUS-like subjects from the ION US Post Approval Study. Assuming that 40% of the total enrolled population is on-label subjects, a total enrollment of 1,115 subjects will be required in the ION US post-approval study.
Primary Endpoints The 12-month CD/MI rate for ION
Secondary Endpoints Annual increase in Academic Research Consortium (ARC) (definite/probable)
ST rate in the PERSEUS-like ION population, starting at 24 months.
Additional secondary endpoints include: 1. Stent Thrombosis (ST) rate, using Academic Research Consortium (ARC) definition (definite/probable) in the following populations: overall subject population, ION on-label subject population and off- label subject population. 2. Rate of longitudinal stent deformation. 3. Overall and ION stent-related MACE rates (cardiac death, MI, TVR). 4. Overall and ION stent-related cardiac death or MI rates. 5. Overall and ION stent-related target vessel failure (TVF) rates. 6. Overall and ION stent-related TVR rates. 7. Overall and ION stent-related cardiac death rates. 8. Overall and ION stent-related MI rates. 9. All death rates 10. Non-cardiac death rates 11. All death or MI rates 12. Historical TAXUS definition stent thrombosis rates