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

A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01328197

Enrollment

Registered

2011-04-04

Start date

2011-06-30

Completion date

2017-06-30

Last updated

2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysms

Keywords

Treovance, aneurysm, AAA

Brief summary

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.

Interventions

DEVICETreovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Stent-graft implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

AAA device

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
major morbidity and mortality	1, 6, 12 months

Secondary

Measure	Time frame	Description
Device performance	implant, 1, 6, and 12 months	Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026