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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Post-Approval Study


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General
Study Status Completed
Application Number P020004 S123/ PAS001
Date Current Protocol Accepted  
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study consists of the extended follow-up data out to 5 years for subjects enrolled in the IBE 12-04 clinical study and continued access.
Study Population Description Subjects with a common iliac or aortoiliac aneurysm, who have appropriate anatomy to accommodate the device and fit the study selection criteria.
Sample Size 64 unique subjects in the IDE cohort and 18 subjects in the continued access cohort.
Data Collection Data will be provided on the following: a summary of the number of patients for whom data are available and the rates of adverse events, such as aneurysm-related mortality, aneurysm rupture, secondary endovascular procedures, conversion to open surgical repair, endoleak, aneurysm enlargement, prosthesis migration and patency, and losses of device integrity.
Follow-up Visits and Length of Follow-up 5 years
Annual
Interim or Final Data Summary
Actual Number of Patients Enrolled The initial cohort enrolled 65 subjects (of which 63 subjects underwent the IBE procedure) and the continued access cohort enrolled 35 subjects.
Actual Number of Sites Enrolled The initial cohort had 29 investigational sites and the continued access cohort had 20 investigational sites.
Patient Follow-up Rate The follow up rate for the initial cohort in the 5-year window was 80% (36/45) with any clinical follow-up and 71.1% (32/45) with CT imaging (66.7% (30/45) with contrast). The follow up rate for the continued access cohort in the 5-year window was 73.9% (17/23) with any clinical follow-up and 69.6% (16/23) with CT imaging (all of which were contrast).
Final Safety Findings The primary safety endpoint result for all eligible initial cohort subjects (n=62) within 30 days of the initial procedure is as follows:
100% were free from all primary safety endpoint events, including: death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure and conversion to open surgical repair.

Additional 5-year safety results are as follows:
68.3% of initial cohort subjects and 71.4% of continued access subjects undergoing the IBE procedure experienced a serious adverse event during the study.
9 initial cohort subjects and 8 continued access subjects died during 5-year follow-up. Deaths were not procedure or device related, and there were no aneurysm-related mortality events.
11.5% of initial cohort (IC) subjects and 14.3% of continued access (CA) experienced a device-related serious adverse event, including type IA endoleak (2.9% CA), type II endoleak (3.3% IC; 2.9% CA), stent graft infection (2.9% CA), aortic dissection rupture (2.9% CA), device occlusion (1.6% IC; 22.9% CA), iliac artery dissection (1.6% IC), and access-related complications such as groin hematoma (1.6% IC), incision site infection (1.6% IC), and vascular pseudoaneurysm (1.6% IC).
Final Effect Findings Primary and secondary effectiveness endpoint results for all eligible initial cohort subjects (n=61) implanted with both IBE Device components at 6 month follow up are as follows:

Primary Effectiveness Endpoint
95.1% of subjects were free from an effectiveness endpoint event through 6 month follow up. Individual endpoint component results include:
100% of subjects were free from complete loss of blood flow in the leg of the IBC or IIC due to thrombus or device failure as assessed by an independent core laboratory,
100% of subjects were free from reintervention of either IBE Device component due to Type 1B or Type III endoleak as determined by the CEC, and
95.1% of subjects were free from reintervention of either IBE Device component in order to re-establish patency due to 60% occlusion or greater as determined by the CEC.

Secondary Effectiveness Endpoint
100% of subjects were free from new onset buttock claudication arising from the side of the body treated with the IBE Device through 6 month follow up.
Study Strengths & Weaknesses Observed study performance was sufficient to meet separate, hypothesis-tested performance goals centered on safety and effectiveness. A secondary effectiveness focused on new onset buttock claudication on the IBE-treated side of the body showed freedom from event through six months post-procedure. Device safety and effectiveness was demonstrated with clinical data through 6 months post procedure. Follow-up data collected after this time point (up to 5 years) showed continued safety and effectiveness in the longer term.

However, study conduct showed a high rate of screen failures that were primarily based on anatomical eligibility, such as common iliac artery lumen diameter, indicating that a portion of an aortoiliac or common iliac artery patient population may not be able to be treated with
the IBE Device in an on-label fashion. The study population was heavily represented by Caucasian males and data in female or non-White populations is limited. Treatment of a bilateral aneurysm patient population was limited.
Recommendations for Labeling Changes Labeling will be modified to reflect the findings of the post-approval study.



Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/28/2017 03/27/2017 Overdue/Received
two year report 02/28/2018 03/09/2018 On Time
three year report 02/28/2019 02/11/2019 On Time
four year report 02/28/2020 02/27/2020 On Time
five year report 02/27/2021 02/24/2021 On Time
final report 02/28/2022 09/30/2021 On Time


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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