Clinical trial NCT02009644: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm (AAA)
Keywords: Abdominal Aortic Aneurysm
AAA
Aneurysm
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: AAA Device
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Efficacy
timeFrame: 12 months
measure: Primary Safety
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 30 days, 6 months, 12 months
measure: Secondary Efficacy Endpoint-- Secondary interventions
timeFrame: 30 days, 6 months, annually
measure: Secondary Efficacy Endpoint -- Device-Related Complications
timeFrame: 30 days, 6 months, and annually
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Heart and Vascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital Heart & Vascular Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rockford
country: United States
facility: Affiliated Surgeons of Rockford Memorial Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinic
state: Iowa
city: Boston
country: United States
facility: Tufts University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester -- Strong Memorial Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University / Pitt County Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Heart Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford University of South Dakota Medical Center
state: South Dakota
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
Study officials:
affiliation: Cleveland Clinic Foundaton
name: Matthew Eagleton, MD
role: PRINCIPAL_INVESTIGATOR
References: