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Clinical Study of the TriVascular Abdominal Stent Graft System

2014-07-23 21:09:45 | BioPortfolio

Summary

The primary objectives of this study are to determine whether the TriVascular AAA Stent Graft is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.

Description

This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the TriVascular Stent Graft when used in the treatment of patients with AAA (Treatment Group) as compared to the surgical control cohort from the Lifeline Registry of Endovascular Aneurysm Repair (Control Group).

150 study patients will be enrolled at up to 40 institutions.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aortic Aneurysm, Abdominal

Intervention

Endovascular Implant of TriVascular AAA Stent Graft

Location

Albany Medical Center
Albany
New York
United States
12208

Status

Recruiting

Source

TriVascular, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:45-0400

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Medical and Biotech [MESH] Definitions

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.

The tearing or bursting of the wall along any portion of the AORTA, such as thoracic or abdominal. It may result from the rupture of an aneurysm or it may be due to TRAUMA.

Cardiovascular manifestations of SYPHILIS, an infection of TREPONEMA PALLIDUM. In the late stage of syphilis, sometimes 20-30 years after the initial infection, damages are often seen in the blood vessels including the AORTA and the AORTIC VALVE. Clinical signs include syphilitic aortitis, aortic insufficiency, or aortic ANEURYSM.

Solitary lesions of bone that typically cause a bulging of the overlying cortex bearing some resemblance to the saccular protrusion of the aortic wall in aortic aneurysm, hence the name. (Dorland, 27th ed)

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