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
The sponsor will use the ongoing PAS that was ordered for P110013, which is a
prospective, multi-center, non-randomized, single-arm, open-label study. The subjects enrolled with the 34mm or 38mm length stents will comprise the ¿Extended Length Sub-study (XL) - New Enrollment Cohort¿.
Study Population Description
Patients who met the inclusion/exclusion criteria for the RESOLUTE INTEGRITY US - XL, evaluating the
Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries (Overall Study and Sub-study).
Sample Size
The observed event rate for the primary endpoints is assumed to be 3.5% so a
sample size of 50 subjects will provide a 95% confidence interval [0.3%, 13.0%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of 56 patients will be conservatively enrolled in this trial to ensure that at least 50 patients will be evaluable at 12 months.
Data Collection
Primary Endpoint
The primary endpoint for all patients enrolled in this study (overall and sub-study) is
the composite rate of cardiac death and target vessel myocardial infarction (MI) at 12 months
Secondary Endpoints
Composite endpoints:
Major Adverse Cardiac Events (MACE)
Target Lesion Failure (TLF)
Target Vessel Failure (TVF)
Cardiac Death and Target Vessel MI
Clinical endpoints:
Death
Myocardial Infarction
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Stent Thrombosis
Stroke
Bleeding complications in general
Dual antiplatelet therapy (DAPT) compliance
In addition, the following will be assessed:
Procedural success
Device success
Lesion success
Followup Visits and Length of Followup
5 years
Frequency of Follow-up Assessments
For XL Sub-study patients: at 30 days, 6 months, 24 months
