VALOR: The Talent Thoracic Stent Graft System Clinical Study

Summary

A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.

Conditions

• Thoracic Aortic Aneurysms

Interventions

DEVICE

Talent Thoracic Stent Graft

TEVAR

Sponsors & Collaborators

• Medtronic Cardiovascular

  lead INDUSTRY

Principal Investigators

• Mark Kaye, MD · Physician's Regional Medical Center

• Phillip Allmendinger, MD · Hartford Hospital

• Mark Bates, MD · CAMC Health System

• Daniel Benckart, MD · West Penn Allegheny Health System

• Paul Bove, MD · William Beaumont Hospitals

• Thomas Bower, MD · Mayo Clinic

• Alfio Carroccio, MD · Mt. Sinai School of Medicine

• Neal Cayne, MD · NYU Vascular Associates

• Frank Criado, MD · Union Memorial Hospital

• Alan Matsumoto, MD · University of Virginia

• Mark Eskandari, MD · Northwestern Memorial Hospital

• Ronald Fairman, MD · University of Pennsylvania

• Mark Farber, MD · University of North Carolina

• James McKinsey, MD · New York Presbyterian (Columbia & Cornell)

• Mark Fillinger, MD · Dartmouth-Hitchcock Medical Center

• H. Edward Garrett, MD · Baptist Memorial Hospital

• Marc Glickman, MD · Sentar Norfolk General

• Kim Hodgson, MD · Memorial Medical Center

• Matthew Jung, MD · Surgical Care Associates

• Barry Katzen, MD · Baptist Health South Florida

• Zvonimir Krajcer, MD · St. Luke's Episcopal Hospital-Houston

• Christopher Kwolek, MD · Massachusetts General Hospital

• Lowell Satler, MD · Medstar Health Research Institute

• Anthony Lee, MD · University of Florida

• Alan Lumsden, MD · Baylor College of Medicine

• Sean Lyden, MD · Cleveland Clinic Foundation-Ohio

• Richard McCann, MD · Duke University

• Manish Mehta, MD · Vascular Group, PLLC

• Mark Mewissen, MD · St. Luke's Vascular Center

• Takao Ohki, MD · Montefiore Medical Center

• Venkatesh Ramaiah, MD · Arizona Heart Institute

• Robert Rhee, MD · Shadyside Hospital-UPMC

• Timothy Roush, MD · Carolinas Medical Center

• Gregoria Sicard, MD · Washington University School of Medicine

• Cary Stowe, MD · AdventHealth

• Jim Swischuk, MD · Saint Francis Hospital

• Michael Tuchek, MD · Loyola University

• Rodney White, MD · Harbor UCLA

• David Williams, MD · University of Michigan

• Christopher Zarins, MD · Stanford University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-07-31

Primary Completion

2006-06-30

Completion

2011-06-30

Countries

• United States

Study Locations