Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatment treovance abdominal aortic stent-graft with navitel delivery system
Phase phase 1
Sponsor Bolton Medical
Start date June 2011
End date April 2013
Trial size 30 participants
Trial identifier NCT01328197, IP-0006-10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
treovance abdominal aortic stent-graft with navitel delivery system
Stent-graft implant

Primary Outcomes

Measure
major morbidity and mortality
time frame: 1, 6, 12 months

Secondary Outcomes

Measure
Device performance
time frame: implant, 1, 6, and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Bolton Medical.