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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100040 / PAS001 |
| Date Original Protocol Accepted |
04/01/2011
|
| Date Current Protocol Accepted |
09/14/2011
|
| Study Name |
Captivia Delivery System
|
| Device Name |
VALIANT THORACIC STENT GRAFT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, single-arm study to assess the freedom from ARM at five years.
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| Study Population |
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
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| 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.
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| Key Study Endpoints |
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.
.
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
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
160
|
| Actual Number of Sites Enrolled |
28
|
| Patient Follow-up Rate |
94%
|
| Final 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).
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| Final Effect Findings |
Five year aneurysm related mortality rate, by KM analysis is 94.8% (with a lower 95% confidence interval of 91.2%)
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| Study 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
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| Recommendations for Labeling Changes |
A change in labeling is recommended to update the results of the PAS.
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