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
Study Objective To evaluate the safety and effectiveness of the Complete SE SFA Stent System in
the treatment of de novo and/or restenotic lesions or occlusions in the superficial femoral (SFA) and/or proximal popliteal (PPA) in subjects with symptomatic peripheral artery disease (PAD).
Study Design Extended follow-up of premarket cohort enrolled in a prospective, multicenter, single arm study. There are no new enrollments.
Study Population Description
All subjects with symptomatic ischemic PAD and above-the-knee lesions enrolled in the Complete SE SFA
IDE study treated with the Complete SE Vascular stent.
Comparator: Performance goal (PG) of 35% event-free rate from acute death, amputation and TLRs.
196 subjects enrolled at 28 sites in the US, Germany and Belgium.
Assumptions for sample
size calculation - 30% attrition of original 196 IDE subjects at 36 month yields 137 PAS subjects - PG: 35% event-free rate from acute death, amputation and TLRs - CSE Stent true event-free rate from acute death, amputation and TLRs = 55.0% - Study Power > 95% - One-sided alpha error of 2.5% - Sample size = 137 subjects evaluable for analysis based on the Exact test of the binomial distribution
Primary endpoint: composite of freedom from acute death, amputation, and TLR events at 36 months.
Secondary endpoints evaluable at 24 and 36 months post implantation: - All-cause mortality - Stent integrity by flat plate x-rays - Acute death, amputation and TLR event rates.
Followup Visits and Length of Followup
3 years post treatment yearly
Final Study Results
Actual Number of Patients Enrolled
187 subjects were available at 12 months for follow-up though 36 month post procedure
Actual Number of Sites Enrolled
28 (23 in the United Sates and 5 in Belgium and Germany)
Patient Followup Rate
84.5% (131/151) at 36 months
Final Safety Findings
Primary Endpoint The event free major adverse event (MAE) rate (composite of acute death, target lesion
or vessel revascularization and target limb Amputation) at 36 months was 69.8%. The lower bound of the 97.5% confidence interval was 62% which is greater than pre-specified performance goal of 35%.
Secondary Endpoints All-cause mortality at 24 and 36 months was 9.8% (18/184) [95% CI: 5.95%, 15.0%] and 14% (25/178) [95% CI: 9.3%, 20.0%], respectively. Stent Integrity at 24 and 36 months was 100% (159/159) [95% CI: 97.7%, 100%] and 100% (145/145) [95% CI: 97.5%, 100%], respectively.
Acute death, amputation and TLR events rate at 24 and 36 months was 22.5% (38/169) [95% CI: 16.4%, 29.5%] and 30.2% (48/159) [95% CI: 23.2%, 38.0%], respectively.
Study Strengths and Weaknesses
The study involved formal hypotheses testing and it met its primary endpoint at 36 months.
PAS population comprised of the premarket cohort that was required to meet certain eligibility criteria. Thus, the study results may not reflect the device performance in routine clinical device.
Recommendations for Labeling Changes
Labeling change is recommended to reflect the 3-year long term results from the post-approval study.
The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow -up visits etc.), results and study strengths and limitations.