Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Bolton Medical

Status and phase

Completed

Phase 1

Conditions

Abdominal Aortic Aneurysms

Treatments

Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01328197

IP-0006-10

Details and patient eligibility

About

The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
Subjects with 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
Subjects who consent to participate
Subjects who agree to comply with the follow-up schedule

Exclusion criteria

Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
Subjects with prior AAA repair
Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
Subjects who are pregnant or lactating
Subjects participating in other investigational studies
Subjects with less than 2 years life expectancy