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

Brief Title

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

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 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 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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Primary Efficacy

Secondary Outcome

 Secondary Safety Endpoint

Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Subjects who receive the Treovance stent-graft

Study Arms / Comparison Groups

 Treovance

Description:  Subjects who receive the Treovance stent-graft

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

150

Start Date

November 23, 2013

Completion Date

June 2025

Primary Completion Date

March 20, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Matthew Eagleton, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02009644

Organization ID

IP-0008-12

Responsible Party

Sponsor

Study Sponsor

Bolton Medical

Study Sponsor

Matthew Eagleton, MD, Principal Investigator, Cleveland Clinic Foundaton

Verification Date

June 2020