Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Interventions
- Device: Subjects who receive the Treovance stent-graft
- Registration Number
- NCT02009644
- Lead Sponsor
- Bolton Medical
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treovance Subjects who receive the Treovance stent-graft Subjects who receive the Treovance stent-graft
- Primary Outcome Measures
Name Time Method Primary Efficacy 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 30 days The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Endpoint -- Device-Related Complications 30 days, 6 months, and annually This endpoint includes the rate of complications associated with the device.
Secondary Safety Endpoint 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 30 days, 6 months, annually The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant
Trial Locations
- Locations (32)
Lynn Heart and Vascular Institute
🇺🇸Boca Raton, Florida, United States
Coastal Vascular and Interventional
🇺🇸Pensacola, Florida, United States
Avera Heart Hospital
🇺🇸Sioux Falls, South Dakota, United States
Sanford University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Affiliated Surgeons of Rockford Memorial Hospital
🇺🇸Rockford, Illinois, United States
Northside Hospital Heart & Vascular Institute
🇺🇸Atlanta, Georgia, United States
University of Iowa Hospital and Clinic
🇺🇸Iowa City, Iowa, United States
Tufts University Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
University of Rochester -- Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Stony Brook Medical Center
🇺🇸Stony Brook, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Sanger Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
East Carolina University / Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Temple University School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States