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
This study will evaluate clinical outcomes on all patients enrolled (excluding those discontinued due to
death) in the RESILIENT Trial through 3 years post-procedure. The RESILIENT (A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent vs. Angioplasty-Alone In Lesions Involving The superficial femoral artery and/or Proximal Popliteal Artery) Trial consisted of two distinct phases, a non randomized, prospective, feasibility study followed by a randomized, prospective, pivotal study. Both phases treated subjects with de novo or restenotic (non-stented) lesion(s) of the native superficial femoral artery and/or proximal popliteal artery. The purpose of the study was to demonstrate the safety and effectiveness of placing the LifeStent NT within the target artery.
Study Population Description
This device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo
or restenotic lesions up to 160 mm in length in the native superficial femoral artery and proximal popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.
Sample Size
246 patients, 20 sites
Data Collection
The Phase I primary safety endpoint was freedom from peri-procedural death, stroke, myocardial infarction, emergent
surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel. The Phase II primary safety endpoint was the mortality rate at 30 days post-procedure. The long term (post-approval) safety endpoints included mortality, major adverse cardiac events, and adverse events. The long term effectiveness measures include acute and chronic assessments.
Followup Visits and Length of Followup
Post discharge clinical follow-up was performed at 1 month, 6 month and annually post-procedure out
to 3 years.
Final Study Results
Actual Number of Patients Enrolled
246
Actual Number of Sites Enrolled
25
Patient Followup Rate
82%
Final Safety Findings
There is no statistically significant difference in time to MACE between the test and control
groups (p = 0.98) for the duration of the study.
The 6, 12, 24 and 36-month major adverse clinical event (MACE) rates show no statistical difference (p-values > 0.78) between the control (PTA) arm and the test (LifeStent NT) arm.
Final Effectiveness Findings
The 36-month freedom from re-intervention and clinical success statistically favored the test group. The test
group fared better than the control group (p <0.0001) for the study's primary effectiveness endpoint, freedom from TLR/TVR at 6-months.
Study Strengths and Weaknesses
There was no statistical justification for the sample size and no specific hypotheses proposed for
