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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Application Number P070014 / PAS002
Current Plan Approved 02/13/2009
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Follow-up Visits and Length of Follow-up Post discharge clinical follow-up was performed at 1 month, 6 month and annually post-procedure out to 3 years.
Final Study Results
Interim Safety Information 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. There was no statistically significant difference (log-rank test) in the survival curves between the test and control groups (p = 0.68) over the duration of the study. At 36-months the probability of surviving is 0.90 (test) and 0.92 (control) (nominal p = 0.71). There is a significant difference in amputation rates between the test (LifeStent) and control (PTA) groups at the 6 and 12-month time points, while there is no significant difference at 24 and 36-months. No significant differences were found in the MACE rate at 6, 12, 24 or 36-months post index procedure. The sponsor notes that the study DSMB concluded that the LifeStent safety was established through 36-months via the trial data which demonstrated major adverse event rates that were not different between test and control groups. The sponsor also notes that LifeStent System demonstrated acute and chronic safety rates that were above the FDA recognized VIVA performance goals (Rocha-Singh, 2007) for SFA intervention.
Number of Patients 246
Number of Sites 25
Follow-up Rate 82%
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.
Effect 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.
Strengths & Weaknesses There was no statistical justification for the sample size and no specific hypotheses proposed for the post-market follow-up.
Label Changes Requested by ODE


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/21/2009 08/31/2009 Overdue/Received
Final report 05/13/2010 05/12/2010 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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