Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02009644
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2013-11-06
Brief Title:
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
Sponsor:
Bolton Medical
Organization:
Bolton Medical
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 US Phase II requirements The data from this study will be submitted to the FDA and used to support approval in the US
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
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 US Phase II requirements The data from this study will be submitted to the FDA and used to support approval in the US
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None