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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Bolton Medical

Current Primary Outcome:

  • Primary Efficacy [ Time Frame: 12 months ]
    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.)
  • Primary Safety [ Time Frame: 30 days ]
    The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)


Original Primary Outcome:

Current Secondary Outcome:

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


Original Secondary Outcome:

Information By: Bolton Medical

Dates:
Date Received: November 6, 2013
Date Started: November 2013
Date Completion: June 2017
Last Updated: August 21, 2015
Last Verified: August 2015