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

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.

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Key information

Conditions

Abdominal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Massachusetts, Worcester, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Device

Stent-graft implant

Primary outcomes

major morbidity and mortality

Time frame: 1, 6, 12 months

Secondary outcomes

Device performance

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bolton Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2017
First posted: Apr 4, 2011
Registry last updated: Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed