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 study is a prospective, multi-center, non-randomized, postmarket surveillance study.
Study Population Description
Study subjects with ischemic heart disease, due to stenotic lesions in either native coronary arteries
or coronary artery bypass grafts undergoing PCI with stent placement and no contraindications to prolonged DAPT and who have received at least one 2.25 mm CYPHER stent during the course of the study.
The study population enrolled in this postmarket surveillance study will supplement the 2.25mm CYPHER data collected from the CYPHER Elite randomized trial. The intent is to combine the data from the CYPHER Elite randomized trial to have a total sample size of 160 patients. This trial is expecting to enroll 160 subjects in which approximately 24 of the subjects will come from the CYPHER Elite trial. Subjects with de novo atherosclerotic coronary artery lesions that are treated with a 2.25mm stent will be eligible for study participation. Subjects must meet all eligibility criteria for inclusion into the study.
A total of 160 patients with de novo coronary artery lesions that are treatable with
a 2.25 mm stent and meet all other inclusion and exclusion criteria will be enrolled into this study. The clinical outcomes and safety data from this protocol will be pooled for analysis with the 2.25mm CYPHER control data from the CYPHER ELITE Stent IDE clinical study, (IDE G070140).
With a sample size of 142, a one-sided ÷2 test using a nominal significance level of 0.05 will have approximately 90% power to reject the null hypothesis when the observed CYPHER 2.25mm TLF rate at 12 months is 21.0%. Assuming a 10% attrition rate over 12 months, enrollment is set at 160 patients. The 160 patients will be a combination of those patients enrolled in this post-market study and those enrolled in the control arm of the Cypher Elite trial.
The primary endpoint of this study is target lesion failure (TLF) defined as clinically-driven
target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12-months post-procedure.
Secondary Endpoints 1.Procedural endpoints: −Lesion success −Device success −Procedure success 2. Clinical endpoints at 12 months post procedure and yearly to 33 months post procedure: −Target lesion revascularization (TLR) −Target vessel revascularization (TVR) −Target vessel failure (TVF) and its individual components −Composite endpoint of all deaths or MI −Composite endpoint of cardiac death or MI −Major adverse cardiac events (MACE) (death, Q wave or WHO-defined non-Q wave myocardial infarction, emergent bypass surgery, or repeat target lesion revascularization) and its individual components 3. Safety endpoints: −Stent thrombosis events (acute, sub-acute, late, very late) (using both ARC and -Protocol- definition) −Bleeding events −Death (cardiac and non-cardiac) −Myocardial Infarction (Q wave or WHO-defined non-Q wave) −Stroke (hemorrhagic and non- hemorrhagic)
Followup Visits and Length of Followup
All subjects enrolled in this study will be followed for 33 months. Follow- up visits
are at 30 days, 6 months, one year, and annually to 33 months.