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

Phase 1

Completed

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

• Registration Number: NCT01328197
• Lead Sponsor: Bolton Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Study Start: 2011-06
• Primary Completion: 2013-04
• Study Completion: 2017-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treovance	Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System	-

Primary Outcome Measures

Name	Time	Method
major morbidity and mortality	1, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Spectrum Health System; 🇺🇸 Grand Rapids, Michigan, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Carolinas Sanger Heart and Vascular; 🇺🇸 Charlotte, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Sentara Heart Hospital; 🇺🇸 Norfolk, Virginia, United States