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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bolton Medical
Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT02009644
First received: November 6, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Abdominal Aortic Aneurysm (AAA)
Device: Subjects who receive the Treovance stent-graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bolton Medical:

Primary Outcome Measures:
  • Primary Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)


Secondary Outcome Measures:
  • Secondary Safety Endpoint [ Time Frame: 30 days, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This endpoint includes the rate of complications associated with the device.


Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treovance
Subjects who receive the Treovance stent-graft
Device: Subjects who receive the Treovance stent-graft
Eligible subjects will be implanted with the Treovance Stent-Graft
Other Name: Treovance Abdominal Stent-Graft with Navitel Delivery System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009644

Contacts
Contact: Julie Byerly 954-838-9699 jbyerly@boltonmedcal.com
Contact: Annie Weiller 954-838-9699 aweiller@boltonmedical.com

  Show 28 Study Locations
Sponsors and Collaborators
Bolton Medical
Investigators
Principal Investigator: Matthew Eagleton, MD Cleveland Clinic Foundaton
  More Information

No publications provided

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT02009644     History of Changes
Other Study ID Numbers: IP-0008-12
Study First Received: November 6, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bolton Medical:
Abdominal Aortic Aneurysm
AAA
Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 11, 2014