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

Sponsor

Bolton Medical (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02009644

Collaborator

(none)

150

Enrollment

Locations

Arm

138.3

Anticipated Duration (Months)

4.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm (AAA)	Device: Subjects who receive the Treovance stent-graft	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

AAA DeviceAAA Device

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 23, 2013

Actual Primary Completion Date :

Mar 20, 2017

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treovance Subjects who receive the Treovance stent-graft	Device: Subjects who receive the Treovance stent-graft Eligible subjects will be implanted with the Treovance Stent-Graft Other Names: Treovance Abdominal Stent-Graft with Navitel Delivery System

Arm

Intervention/Treatment

Experimental: Treovance

Subjects who receive the Treovance stent-graft

Device: Subjects who receive the Treovance stent-graft

Eligible subjects will be implanted with the Treovance Stent-Graft

Other Names:

Treovance Abdominal Stent-Graft with Navitel Delivery System

Outcome Measures

Primary Outcome Measures

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

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
Secondary Efficacy Endpoint -- Device-Related Complications [30 days, 6 months, and annually]
This endpoint includes the rate of complications associated with the device.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama-Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Heart Institute	Phoenix	Arizona	United States	85006
3	Danbury Hospital	Danbury	Connecticut	United States	06810
4	Lynn Heart and Vascular Institute	Boca Raton	Florida	United States	33486
5	Coastal Vascular and Interventional	Pensacola	Florida	United States	32504
6	Northside Hospital Heart & Vascular Institute	Atlanta	Georgia	United States	30342
7	University of Chicago	Chicago	Illinois	United States	60637
8	Affiliated Surgeons of Rockford Memorial Hospital	Rockford	Illinois	United States	61103
9	University of Iowa Hospital and Clinic	Iowa City	Iowa	United States	52242
10	Tufts University Medical Center	Boston	Massachusetts	United States	02111
11	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
12	University of Massachusetts	Worcester	Massachusetts	United States	01655
13	Spectrum Health System	Grand Rapids	Michigan	United States	49503
14	Mayo Clinic	Rochester	Minnesota	United States	55905
15	Albany Medical Center	Albany	New York	United States	12205
16	Buffalo General Medical Center	Buffalo	New York	United States	14203
17	Mount Sinai Medical Center	New York	New York	United States	10029
18	University of Rochester -- Strong Memorial Hospital	Rochester	New York	United States	14623
19	Stony Brook Medical Center	Stony Brook	New York	United States	11794-8191
20	Mission Hospital	Asheville	North Carolina	United States	28801
21	Sanger Heart and Vascular Institute	Charlotte	North Carolina	United States	28203
22	East Carolina University / Pitt County Memorial Hospital	Greenville	North Carolina	United States	27834
23	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
24	The Ohio State University	Columbus	Ohio	United States	43210
25	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
26	Temple University School of Medicine	Philadelphia	Pennsylvania	United States	19140
27	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232
28	York Hospital	York	Pennsylvania	United States	17403
29	Rhode Island Hospital	Providence	Rhode Island	United States	02905
30	Avera Heart Hospital	Sioux Falls	South Dakota	United States	51108
31	Sanford University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117
32	Sentara Vascular Specialists	Norfolk	Virginia	United States	23507