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

Not Applicable

Active, not recruiting

• Conditions: Abdominal Aortic Aneurysm (AAA)

• 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.

Study Timeline

• Study First Submitted: 2013-11-06
• Study Start: 2013-11-23
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Primary Completion: 2017-03-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

Lynn Heart and Vascular Institute; 🇺🇸 Boca Raton, Florida, United States

Coastal Vascular and Interventional; 🇺🇸 Pensacola, Florida, United States

Northside Hospital Heart & Vascular Institute; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Affiliated Surgeons of Rockford Memorial Hospital; 🇺🇸 Rockford, Illinois, United States

University of Iowa Hospital and Clinic; 🇺🇸 Iowa City, Iowa, United States

Tufts University Medical Center; 🇺🇸 Boston, Massachusetts, United States

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