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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the
TAXUS Liberte-Paclitaxel-Eluting Coronary Stent and prasugrel as part of a dual antiplatelet therapy drug regimen. This is a consecutively-enrolled study with follow-up through 5 years. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy study.
Study Population Description
Patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or
coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with TAXUS Liberté stent placement and no contraindications to prolonged DAPT.
Approximately 4,200 consecutive, eligible patients will be enrolled at up to 100 U.S. sites. Primary Endpoint Given
the non-inferiority margin of 1.6% and a one-sided 5% significance level, 2,363 on-label TAXUS Liberté patients would be required to provide 80% power to test the hypothesis for the primary endpoint. Secondary Endpoints A total of 2,100 on-label patients treated with the TAXUS Liberté stent and followed through 3 years post stent index procedure is required. To allow for approximately 3.5% attrition per year, 2,546 on-label patients will be required to provide at least 2,100 on-label patients through 3-year follow-up. This will include 871 patients enrolled in the TAXUS ATLAS Workhorse protocol and 1,675 on-label patients enrolled into the TAXUS Liberté Post Approval Study.
The rate of Cardiac Death or Myocardial Infarction (MI) among all on-label patients through 12
months or survive free of Cardiac Death or MI for at least 335 days (Day 365 minus 30 days). Secondary Endpoints 1. Stent thrombosis (ST) rate, using the historical TAXUS definition in the following populations: overall patient population, TAXUS Liberté on-label population, TAXUS Liberté off-label population. 2. ST rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Revascularization) in the following populations; overall patientpopulation, TAXUS Liberté on-label patient population and off-label patient population. 3. Overall and TAXUS-related MACCE rates (cardiac death, myocardial infarction, target vessel revascularization, stroke). 4. Overall and TAXUS-related cardiac death, MI or stroke rates. 5. Overall and TAXUS-related MACE rates (cardiac death, myocardial infarction, target vessel revascularization). 6. Overall and TAXUS-related cardiac death or MI rates. 7. Overall and TAXUS-related target vessel failure (TVF) rates. 8. Overall and TAXUS-related target vessel revascularization (TVR) rates. 9. Overall and TAXUS-related MI rates. 10. Overall and TAXUS-related cardiac death rates. 11. All cause death rate. 12. Non-cardiac death rate. 13. All death or MI rate. 14. All stroke rate. 15. Rate of bleeding complication will be studied separately for GUSTO classifications severe and moderate as well as for major bleeding (the composite of GUSTO severe + moderate bleeding).
Followup Visits and Length of Followup
Patients will be consecutively-enrolled and followed up through a minimum of three years. Length of Follow-up All
patients will be followed for a minimum of three years. For patients who are unblinded at 30 months, determined to have been randomized to prasugrel (blinded), and subsequently provided with additional prasugrel: the 36-month follow-up visit should be conducted as an office visit. In addition, a 42-month follow-up visit is required for this subset of patients by telephone or office visit.