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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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OSB Lead-Continued Follow-up of Premarket Cohort


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General
Study Status Completed
Application Number P100018 / PAS001
Date Current Protocol Accepted 06/27/2011
Study Name OSB Lead-Continued Follow-up of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single arm prospective cohort
Study Population Description Pipeline Embolic Device pivotal study cohort and the (device and control continued access cohort follow up. These were patients group) with wide-necked intracranial aneurysms in the internal

carotid artery from the petrous to the superior hypophyseal segments.

Sample Size (no. 134 subjects, 2-subgroup analyses by aneurysm location

study sites and and by hypertension status

patients)

Data Collection Ipsilateral stroke or neurovascular death Secondary: complete occlusion of treated aneurysm,

stenosis of the parent artery in PED, and device-related adverse events.

Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled Out of 138 consented patients, 135 patients were enrolled in the PUFS-PAS (108 PUFS between November 2008 and July 2009 + 27 PUFS-CA between May 2010 and April 2011) of which 134 PUFS- PAS patients were treated with the PED and 1 PUFS patient was not treated with the PED.
Actual Number of Sites Enrolled 12 centers (10 US, 2 OUS (1 Hungary, 1 Turkey)).
Patient Follow-up Rate 3- year follow-up rate: 107 / 130 (82.3%) 5-year follow-up rate: 100/128 (78.1%)



Note: These are general follow-up rates. For specific endpoints (e.g. safety and effectiveness endpoints requiring the use of angiography), the follow-up rate may be less, potentially leading to selection bias, which may leads to an underestimate of rates for adverse events or complications.

Final Safety Findings The primary endpoint (incidence of ipsilateral stroke or neurovascular death at 5-year follow-up) was 8.3% (11/134; 95% CI: 4.7%-14.4%), meeting the threshold of success of < 25%.



There was no significant difference according to aneurysm location (at or below cavernous segment vs. at or above ophthalmic segment) in incidence of ipsilateral stroke or neurovascular death at 5-year follow-up.

There was a significantly higher incidence of ipsilateral stroke or neurovascular death at 5- year follow-up (P=0.0067) among patients with a history of hypertension (10/70 (14.3%)) vs. patients without a history of hypertension (1/64 (1.6%)).



Seven device related adverse events were observed during the long-term follow-up period:

5-year follow-up: 7 / 106 (6.6%)

0- to 3-year follow-up: 5/106 (4.7%)

4- to 5-year follow-up: 2/99 (2.0%)

Parent artery stenosis:



3 years 5 years

0-25% 80% (80/100) 80% (64/80)

>25-50% 8.0% (8/100) 5.0% (4/80)

>50%-75% 0.0% (0/100) 1.3% (1/80)

>75% 3.0% (3/100) 2.5% (2/80)

Indeterminate 9.0% (9/100) 11.3% (9/80)



Note: A total of 100 out of 106 patients had available parent artery stenosis data at 3 years of follow- up and a total of 80 out of 99 patients had available parent artery stenosis data at 5 years of follow- up. Therefore, follow-up rate is less than the overall follow-up rate at 3 years and 5 years. The finding that parent artery stenosis is less problematic at 5 years of follow-up as compared to 3 years of follow-up may be explained by selection bias.



Opthalmic artery flow at 1-year follow-up was 49 / 65 or 75.4% of patients.

Final Effect Findings Complete aneurysm occlusion at 3-year follow-up was 90 / 100 or 90.0%.

Complete aneurysm occlusion at 5-year follow-up was 75 / 80 or 93.8%.

Study Strengths & Weaknesses Strengths:

The prospective cohort design may be less prone to bias. Long-term follow-up of patients until 5 years post-procedure.

Powered to meet objective performance criterion for primary endpoint.

Definitions of safety and effectiveness endpoints facilitate comparison with literature.

Pre-specified primary, secondary and descriptive safety and effectiveness endpoints as well as sub- group analyses.

Follow-up rates were acceptable, limiting selection bias.

Independent assessment of endpoints, limiting misclassification bias.

Sensitivity analyses were performed to account for losses to follow-up.



Weaknesses:

Primary endpoint is composite in nature and there is not enough power to evaluate components of this safety endpoint.

Findings from worst-case imputation were inconsistent with findings from optimistic, completers, Kaplan-Meier and predictive distribution, with regard to 5-year complete occlusion rate and 5-year parent artery stenosis of 0-25%.

The 3-year follow-up rate was 107 / 130 (82.3%) and the 5-year follow-up rate was 100/128 (78.1%). However, these are general follow-up rates. For specific endpoints (e.g. safety and effectiveness endpoints requiring the use of angiography), the follow-up rate may be less, potentially leading to selection bias.

Recommendations for Labeling Changes A history of hypertension is associated with increased risk of ipsilateral stroke or neurovascular death following PED treatment.


OSB Lead-Continued Follow-up of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/05/2011 10/05/2011 On Time
one year report 04/05/2012 05/23/2012 Overdue/Received
18 month report 10/04/2012 10/04/2012 On Time
two year report 04/05/2013 04/23/2013 Overdue/Received
three year report 04/05/2014 04/07/2014 Overdue/Received
four year report 04/05/2015 04/06/2015 Overdue/Received
60 month report (5 year) 05/23/2016 05/23/2016 On Time
Final Report 12/22/2016 12/23/2016 Overdue/Received
Amended 5 year report 12/23/2016 12/23/2016 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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