• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

PREMIER Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number P100018 S015/ PAS001
Study Name PREMIER Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The “Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline™ Device” (PREMIER) study is a prospective, multi-center non-randomized clinical study evaluating safety and effectiveness outcomes in patients with small or medium wide-necked intracranial aneurysms measuring less than or equal to 12 mm who are treated with the Pipeline™ device. The study includes continued follow-up of the premarket cohort for up to three (3) years post-procedure.
Study Population Description The study enrolled patients with small or medium wide-necked intracranial aneurysms measuring =12 mm who were treated with the Pipeline™ device.
Sample Size Out of 197 consented patients, 141 patients were implanted with the Pipeline device.
Data Collection The primary safety endpoint is the rate of major or disabling strokes or neurological deaths.

The primary effectiveness endpoint is the rate of patients who have complete (100%) Raymond-Roy Class I intracranial aneurysm occlusion without clinically significant parent artery stenosis or retreatment of the target aneurysm.

Follow-up Visits and Length of Follow-up Three years
Interim or Final Data Summary
Actual Number of Patients Enrolled Consented 197 subjects to meet the 141 evaluable (ITT) subjects.
Actual Number of Sites Enrolled 23 sites with 22 US sites and 1 Canadian site
Patient Follow-up Rate The follow-up rates for ITT population at 1-yr, 2-yr, and 3-yr follow-up visits are 98.6%, 95%, and 90.8%, respectively.
Final Safety Findings Incidence of major stroke: Major strokes in the territory supplied by the treated artery or Neurological Death at long-term (2-year and 3-year follow-up) occurred in 2.8% (4/141) of subjects. The incidence rate of major stroke at long-term is comparable with the rate at 1-year follow-up (2.4%). Specifically, only 1 additional subject (Subject: 109-022) experienced a Major Stroke between 1- and 2-year follow-up; none of the subjects had neurological death in this period. No additional Major Stroke in the territory supplied by the treated artery or Neurological Death occurred between 2- and 3-year follow up.

Delayed ICH: The rate of delayed ICH at long-term (1.4%) is comparable with the rate at 1-year follow-up (0.73%). Specifically, only one subject (Subject: 109-022) had a delayed ICH between 1- and 2-year follow-up. No additional delayed intracerebral hemorrhage occurred between the 2- and 3-year follow up.

Device-Related Neurological Adverse Event Rate: Fifteen of the 141 subjects (10.6%, 15/141) experienced device-related neurological AE’s through 3-years post-procedure. The rate of device-related neurological AE is comparable to that at 1-year follow-up (7.8%). Specifically, 4 new subjects reported device-related neurological events between 1- and 2- year follow-up. No additional device-related neurological AE’s occurred between 2- and 3-year follow-up 10.6% (15/141) of subjects.

Cerebrovascular Events: The incidence rates for intracranial hemorrhage (ICH) at 1-yr, 2-yr, and 3-yr follow-up are 0.7%, 0.7%, and 0% respectively. Similarly, the incidence rates for ischaemic stroke at 1-yr, 2-yr, and 3-yr follow-up are 0.7%, 0%, and 0% respectively. There is no increase in the annual incidence rates of hemorrhagic and ischaemic cerebrovascular events over time.

Final Effect Findings Complete aneurysm occlusion rate without significant parent artery stenosis (= 50%) or retreatment of the target aneurysm at 1-year follow up is 78.98% (LCL: 72.05%) with 1-sided 97.5% exact binomial lower bound of 72.05%. Similarly the Complete aneurysm occlusion rates Using LOCF (last observation carry forward) approach at 2-year follow-up and 3-year follow-up are 78.8% (LCL: 70.8%) and 80.3% (LCL: 72.5%), respectively.
Study Strengths & Weaknesses Strength: A prospective and long-term study with follow-up rate for ITT population above 90%.

Weaknesses: Single arm study not controlling for confounding factors. Gender distribution is skewed. The majority of study subjects were female (87.9%) and male subjects were under presented, which leads to a limitation in the generalizability of the study results. Understanding of device performance in subjects vertebral aneurysms is limited due to small sample size (N=7).

Recommendations for Labeling Changes Yes


PREMIER Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report-final 09/15/2019 10/16/2019 Overdue/Received


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Related Links

-
-