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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Captivia Delivery System


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General
Application Number P100040 / PAS001
Current Plan Approved 09/14/2011
Study Name Captivia Delivery System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, single-arm study to assess the freedom from ARM at five years.
Study Population Description The study involves follow-up of the VALOR II cohort. Criteria for being in this study include: age between 18 and 85; a candidate for elective repair of an aneurysm of the descending thoracic aorta; either a fusiform aneurysm with a maximum diameter of at least 5 cm or at least two times the diameter of the non-aneurysmal thoracic aorta, and/or a saccular aneurysm; aneurysm meets the specified anatomic criteria
Sample Size Based on the need for a statistical power of 80%, using a one-sided 95% confidence level, an estimated ARM free rate of 94%, and a performance goal of 83.6%, the sponsor calculates a required sample size of 117 at five years. Assuming a 15% annual attrition rate, that calculates out to an initial sample size of 160, which is the number of patients that will be followed from the IDE study. Those patients were enrolled from 24 sites.
Data Collection Primary Endpoint

The primary endpoint of the study is aneurysm-related mortality at five years, defined as:



Death from rupture of the fusiform aneurysm or saccular aneurysm/penetrating ulcer or from any procedure intended to treat the fusiform aneurysm or saccular aneurysm/penetrating ulcer. If a death occurred within 30 days of any procedure intended to treat the fusiform aneurysm or saccular aneurysm/penetrating ulcer, then it is presumed to be aneurysm related.

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Secondary Endpoints

All-cause mortality

Aneurysm rupture

Conversions to open surgical repair

Endoleaks

Secondary endovascular procedures

Stent graft migration

Loss of stent graft patency, defined as loss of continued blood flow through the treated vessel

Major adverse events
Follow-up Visits and Length of Follow-up Five years
Final Study Results
Number of Patients 160
Number of Sites 28
Follow-up Rate 94%
Safety Findings The majority of aneurysms at all time periods either decrease in size or show no change in size from baseline. From one month to 4 years, 6% or less of aneurysms increased in size. At 5 years the percent of aneurysms increased in size is 11%, much smaller than the percent that decreased in size (48%). These results are consistent with results regarding the consequences of increases in aneurysm size: Low abdominal aortic aneurysm (AAA)-related mortality, no surgical conversions to open surgery since the post- approval study (PAS) began, only one aneurysm rupture since the PAS began, and a rate of secondary interventions for any reason of about only 3% per year. They are also consistent with results regarding the causes of increases in aneurysm size: No stent graft migration or loss of

stent graft patency, and only approximately a 5% rate of endoleaks per year following the start of the PAS (compared to 13% in the 12 months of the clinical trial).

Effect Findings Five year aneurysm related mortality rate, by KM analysis is 94.8% (with a lower 95% confidence interval of 91.2%)
Strengths & Weaknesses Strength: Prospective study

Device met its performance goal by a large margin (lower bound of 95% confidence interval)

Weakness: No concurrent control group

No control for potential confounding variables

Label Changes A change in labeling is recommended to update the results of the PAS.


Captivia Delivery System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/30/2011 09/28/2011 On Time
one year report 03/31/2012 03/29/2012 On Time
18 month report 09/29/2012 09/28/2012 On Time
two year report 03/31/2013 03/26/2013 On Time
three year report 03/31/2014 03/27/2014 On Time
four year report-final report 03/31/2015 01/23/2015 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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