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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

NCT02009644

Abdominal Aortic Aneurysm (AAA)

ACTIVE_NOT_RECRUITING NA

Post-Approval Study of the TREO Abdominal Stent-Graft System

NCT04697784

Abdominal Aortic Aneurysm

ACTIVE_NOT_RECRUITING NA

Global Post-market Registry for the Treovance Stent-graft.

NCT03449875

Abdominal Aortic Aneurysm

COMPLETED

A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

NCT00646048

Abdominal Aortic Aneurysm

COMPLETED PHASE1

Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

NCT07026877

Abdominal Aortic Aneurysms (AAA)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Aortic Aneurysms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

AAA device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treovance

Group Type EXPERIMENTAL

Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Intervention Type DEVICE

Stent-graft implant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Stent-graft implant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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