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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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Long Term/Pivotal Cohort


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General
Study Status Completed
Application Number P040002 / PAS001
Date Current Protocol Accepted  
Study Name Long Term/Pivotal Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study included all surviving endovascular patients from the original pivotal study cohort. There were no hypotheses was proposed to evaluate long-term (5-year) safety and effectiveness.
Study Population Description The Endologix, Inc. Powerlink System is an endovascular stent graft and delivery system that is indicated for endovascular treatment of abdominal aortic aneurysms.
Sample Size 192 endovascular sten graft patients and 66 control patients across 15 sites
Data Collection The primary effectiveness endpoint was all cause mortality. Primary safety endpoint was the incidence of major adverse events including: death, myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, secondary procedures, conversion to open surgical repair, stroke, blood loss, prosthesis migration, and patency.
Follow-up Visits and Length of Follow-up Clinical follow-up and diagnostic test evaluations were scheduled pre-discharge, at one month, six months, one year and annually thereafter through five years.
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled 192 endovascular stent graft patients and 66 control patients
Actual Number of Sites Enrolled 15 sites
Patient Follow-up Rate 56% in the device group, 39% in the control group
Final Safety Findings The overall implant success rate was 98% (188/192), with three patients requiring conversion to open surgical aneurysm repair. Of the 192 device patients, 108 (56.2%) patients were followed (107 had CT imaging follow-up), 43 (22.4%) patients had died, 4 (2.1%) had a conversion to open repair, and 37 (19.3%) withdrew or were lost to follow-up at 5 years. Of the 66 surgical controls 26 (39.4%) patients were followed, 15 (22.7%) patients had died, and 25 (38.9%) withdrew or were lost to follow-up at 5 years. There were four reported aneurysm related deaths in the device group. There were no deaths due to aneurysm rupture. The deaths occurred at 1-day, 9-days, 33-days, and 403-days. The late death occurred during a conversion to open repair. There does not appear to be a problem with a late failure rate in the device.
Study Strengths & Weaknesses Weakness: Higher proportion of patients wtithdrew or were lost to follow-up in control group (39%) Therere 19% of patients who withdrew or were lost to follow-up in the device group.
Recommendations for Labeling Changes None


Long Term/Pivotal Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3rd Annual PAS report 12/14/2007 12/14/2007 On Time
4 year PAS report 10/28/2008 12/18/2008 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

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