Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Detailed Description
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This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S. There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms: Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days Secondary objectives involve assessment of major device-related events and major morbidity.

Official Title
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A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Conditions
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Abdominal Aortic Aneurysm (AAA)

Intervention / Treatment
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* Device: Subjects who receive the Treovance stent-graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months Exclusion Criteria: Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician) Subject has had a prior AAA repair (endovascular or surgical) Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: AAA Device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treovance<br>Subjects who receive the Treovance stent-graft | Device: Subjects who receive the Treovance stent-graft<br>* Eligible subjects will be implanted with the Treovance Stent-Graft<br>* Other names: Treovance Abdominal Stent-Graft with Navitel Delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy | Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.) | 12 months | 
| Primary Safety | The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint | Secondary safety endpoints will include each individual rate for the adverse events included in the composite MAE at 30 days, 6 months, and annually. | 30 days, 6 months, 12 months | 
| Secondary Efficacy Endpoint-- Secondary interventions | The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant | 30 days, 6 months, annually | 
| Secondary Efficacy Endpoint -- Device-Related Complications | This endpoint includes the rate of complications associated with the device. | 30 days, 6 months, and annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, AAA, Aneurysm