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 sub-study of the ongoing Resolute Integrity PAS, ordered for P110013, which is
a prospective, multi-center, non- randomized, single-arm, open-label study.
To assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in two groups of patients, specifically those patients receiving stents ¡Ü 30 mm in length, referred to as the Primary Enrollment Group (PEG) and those patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Sub-study (XL Sub-study).
Study Population Description
Patients who met the inclusion/exclusion criteria for the RESOLUTE INTEGRITY US (RI-US) - XL, evaluating the
Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries (Overall Study and Sub-study). The subjects enrolled with the 34mm or 38mm length stents will comprise the ¡°Extended Length Sub-study (XL) - New Enrollment Cohort¡±.
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. Centers are allowed to enroll a maximum of sixteen (16) XL Sub-study patients per center or until study enrollment has been completed, whichever comes first.
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
The length of follow-up is 5 years. Frequency of Follow-up Assessments: 30 days, 6 months, 24
months and annually at 3, 4, and 5 years post procedure.
The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 24 months. The total time for the duration from first-subject enrolled to last-subject follow-up complete is approximately 7 years.