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

Abdominal Aortic Aneurysm (AAA) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02009644
• Other study ID #: IP-0008-12
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm (AAA)
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

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