|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120006 / PAS002 |
| Date Original Protocol Accepted |
10/05/2012
|
| Date Current Protocol Accepted |
08/28/2013
|
| Study Name |
Training Program
|
| Device Name |
OVATION ABDOMINAL STENT GRAFT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, consecutively enrolling, single-arm, non-randomized, multi- center study
|
| Study Population |
Patients with abdominal aortic aneurysm with vascular morphology suitable for endovascular repair with the Ovation/Ovation Prime Abdominal Stent Graft System. Eligible patients must have met or must meet all of the inclusion criteria and none of the exclusion criteria.
Patients will be categorized into those treated by physicians
¿ who completed fewer than 20 endovascular repairs of AAA with any endovascular graft in the 2 years preceding participation in the Ovation physician training program, and those
¿ who completed 20 or more cases in the preceding 2 years.
|
| Sample Size |
A total 320 subjects comprises of 161 pivotal cohort subjects, all continued access subjects, all subjects from the HDE PAS and at least 59 de novo subjects enrolled from a minimum of 15 U.S. sites.
|
| Key Study Endpoints |
At Implant
Technical failure
Type 1 endoleak
Use of Accessory device
Through 30 days
Serious Adverse Events (SAEs)
Mortality (AAA-related and all-cause)
Device Patency
Conversion to open surgical repair
Endoleak
AAA enlargement
Stent Graft Migration
Device integrity
Secondary endovascular procedures
Aneurysm rupture
|
| Follow-up Visits and Length of Follow-up |
30 days
At implant and 30 days
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
320
|
| Actual Number of Sites Enrolled |
49
|
| Patient Follow-up Rate |
100% at 30 days
|
| Final Safety Findings |
N/A
|
| Final Effect Findings |
At Implant
Endpoint results for physicians with fewer than 20 prior endovascular repairs and physicians with 20 or more prior endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: Technical failure 0% for both physician groups, Type 1 endoleak 0% vs. 0.7% (95% CI for difference 0.7%: -2.9%, 4.2%), and Use of Accessory devices 5.0% vs.8.7% (95% CI for difference 3.7%: -8.9%, 16.3%), respectively.
Through 30 days post Implant
The adverse events rates for physician with fewer than 20 endovascular repairs and physicians with 20 or more endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: AAA-related secondary endovascular procedures 0% vs. 1.0%, device-related SAEs 0% vs.
1.3%, and renal events (including acute kidney injury, renal insufficiency, renal failure) 0% vs. 1.7%, respectively. No statistically significant differences were observed between the 2 groups for any adverse event. The rates for thromboembolic events, paralysis/paraparesis, stroke, claudication and ischemic colitis were 0% in both physician groups.
|
| Study Strengths & Weaknesses |
The study achieved the target enrollment of 320 patients with 100% follow-up at 30days and a high technical success. Patient enrollment in the physicians with fewer than 20 prior endovascular experience group was low.
|
| Recommendations for Labeling Changes |
Labeling change NOT Recommended
|
