|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070027 / PAS001 |
| Date Original Protocol Accepted |
04/15/2008
|
| Date Current Protocol Accepted |
11/05/2008
|
| Study Name |
Vitality Trial
|
| Device Name |
THE TALENT ABDOMINAL STENT GRAFT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, one armed, non-randomized, observational, multi-site study. The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and
effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.This study incorporates the Test Group from the Talent Abdominal PMA (eLPS cohort), consisting of 166 subjects. In addition, 94 new subjects will be prospectively enrolled to compliment the PMA subjects. All subjects are followed for a total of 5 years following initial implantation.
|
| Study Population |
Subjects will include patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved indications for use. The stent graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having: 1) Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) - A proximal aortic neck length of > 10 mm; 3) Proximal aortic neck angulation < 60 ; 4) Distal iliac artery fixation length of > 15 mm; 5) An aortic neck diameter of 18-32 mm and iliac artery diameters of 8-22 mm; and 6) Vessel morphology suitable for endovascular repair.
|
| Sample Size |
166 subjects from the premarket cohort, 94 new subjects from 20-30 sites
|
| Key Study Endpoints |
Primary endpoint: Freedom from aneurysm-related mortality at 5 years. Death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the abdominal aortic aneurysm. If a death occurred within 30 days of any procedure intended to treat the abdominal aortic aneurysm, then it is presumed to be aneurysm related.
|
| Follow-up Visits and Length of Follow-up |
Subjects are followed at 1-month, 6-months, 12-months, 24 months, 36 months, 48 months, and 60 months post-implant. Total duration of follow-up is 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
260
|
| Actual Number of Sites Enrolled |
20
|
| Patient Follow-up Rate |
72.7%
|
| Final Safety Findings |
There were three aneurysm-related deaths in the first 30 days, two more in year one, one in year two, and one in year three. The Kaplan-Meier estimate for freedom from AAA-related mortality was 97.0% at five years (lower 95% limit of confidence interval at five years was 95.0%). There were very few aneurysm ruptures, conversions to open surgery, problems with stent graft patency, integrity, or migration, Type I and III endoleaks have remained at less than 3% annually combined.
|
| Final Effect Findings |
Technical implant success was 98%
|
| Study Strengths & Weaknesses |
Although mortality, aneurysm-related mortality, and secondary procedures were found to be higher than that in males, and although the major adverse event rates were found to be higher in non-whites than in whites, the sample sizes for females (n = 33) and non-whites (n = 19) were far too small for adequate statistical comparisons of these variables.
|
| Recommendations for Labeling Changes |
No
|
