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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02009644
Other study ID # IP-0008-12
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 23, 2013
Est. completion date June 2025

Study information

Verified date September 2023
Source Bolton Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date June 2025
Est. primary completion date March 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Device:
Subjects who receive the Treovance stent-graft
Eligible subjects will be implanted with the Treovance Stent-Graft

Locations

Country Name City State
United States Albany Medical Center Albany New York
United States Mission Hospital Asheville North Carolina
United States Northside Hospital Heart & Vascular Institute Atlanta Georgia
United States University of Alabama-Birmingham Birmingham Alabama
United States Lynn Heart and Vascular Institute Boca Raton Florida
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts University Medical Center Boston Massachusetts
United States Buffalo General Medical Center Buffalo New York
United States Sanger Heart and Vascular Institute Charlotte North Carolina
United States University of Chicago Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Danbury Hospital Danbury Connecticut
United States Spectrum Health System Grand Rapids Michigan
United States East Carolina University / Pitt County Memorial Hospital Greenville North Carolina
United States University of Iowa Hospital and Clinic Iowa City Iowa
United States Mount Sinai Medical Center New York New York
United States Sentara Vascular Specialists Norfolk Virginia
United States Coastal Vascular and Interventional Pensacola Florida
United States Temple University School of Medicine Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Heart Institute Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States Mayo Clinic Rochester Minnesota
United States University of Rochester -- Strong Memorial Hospital Rochester New York
United States Affiliated Surgeons of Rockford Memorial Hospital Rockford Illinois
United States Avera Heart Hospital Sioux Falls South Dakota
United States Sanford University of South Dakota Medical Center Sioux Falls South Dakota
United States Stony Brook Medical Center Stony Brook New York
United States University of Massachusetts Worcester Massachusetts
United States York Hospital York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Efficacy 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.) 12 months
Primary Primary Safety The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.) 30 days
Secondary Secondary Safety Endpoint Secondary safety endpoints will include each individual rate for the adverse events included in the composite MAE at 30 days, 6 months, and annually. 30 days, 6 months, 12 months
Secondary Secondary Efficacy Endpoint-- Secondary interventions The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant 30 days, 6 months, annually
Secondary Secondary Efficacy Endpoint -- Device-Related Complications This endpoint includes the rate of complications associated with the device. 30 days, 6 months, and annually
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