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

NCT ID: NCT01328197

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Abdominal Aortic Aneurysms

Keywords

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Treovance aneurysm AAA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

AAA device
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treovance

Group Type EXPERIMENTAL

Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Intervention Type DEVICE

Stent-graft implant

Interventions

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Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Stent-graft implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bolton Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Spectrum Health System

Grand Rapids, Michigan, United States

Site Status

Carolinas Sanger Heart and Vascular

Charlotte, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Sentara Heart Hospital

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IP-0006-10

Identifier Type: -

Identifier Source: org_study_id