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 post-approval study (PAS) uses the pooled data from the PROTECT and PROTECT Continued Access
(CA) studies in on-label patients to evaluate the annual rates of stent thrombosis (ST) and cardiac death (CD) plus myocardial infarction (MI) for all Endeavor on-label patients.
The PROTECT study is a prospective, multi-center, randomized, two-arm, open-label study. The primary objective is to compare the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System versus the Cypher Sirolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.
The PROTECT CA study is a prospective, multi-center, non-randomized, single-arm, open label study. The primary objective is to evaluate the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.
Study Population Description
The PROTECT and PROTECT CA patient populations include consecutive patients eligible for drug-eluting stent implantation
in one or more target lesions. Patients with lesions in native coronary arteries who met all eligibility criteria were enrolled.
A minimum of 1,000 Endeavor patients will be enrolled in the US, including:
a. US patients enrolled
in the PROTECT study and randomized to ¿Endeavor¿; and
b. US patients enrolled in a single arm fashion in PROTECT CA.
Sites: 60 to 100 US sites
ST rate defined as definite and probable stent thrombosis, according to the ARC
CD/MI composite endpoint. CD defined as any death due to immediate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia). MI per Medtronic historical definition (Q wave or non-Q wave MI).
Followup Visits and Length of Followup
Length of follow-up: 5 years
Follow up at: 1, 6 , 12, 18, 24, 30, 36,
48, and 60 months
Final Study Results
Actual Number of Patients Enrolled
The PAS analyses included 1,769 on-label patients.
Actual Number of Sites Enrolled
Patient Followup Rate
At five years the follow-up rate was 94.6% (1673/1769).
Final Safety Findings
The annual rate of ARC-defined definite and probable stent thrombosis at 5 years for on-label
PROTECT and PROTECT CA studies was 0.06% (1/1673, upper 95% CI: 0.28%, p<0.001).
Final Effectiveness Findings
The 5-year cumulative rate of cardiac death or myocardial infarction for on-label patients in PROTECT
and PROTECT CA studies was 6.40% (107/1673). This rate is below the performance goal of 8.4% (p<0.001)
Study Strengths and Weaknesses
The study had a low rate of attrition, thus minimizing selection bias. The study met
its performance goals and had a large sample size showing a long-term outcome of the stent
Recommendations for Labeling Changes
A labeling change is not needed because Medtronic Vascular has ceased manufacturing and distribution of