Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medtronic Endovascular |
---|---|
Information provided by: | Medtronic Endovascular |
ClinicalTrials.gov Identifier: | NCT00604799 |
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.
Condition | Intervention | Phase |
---|---|---|
Thoracic Aortic Aneurysms |
Device: Talent Thoracic Stent Graft |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms |
Enrollment: | 359 |
Study Start Date: | July 2003 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Test: Active Comparator
Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, & 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery & 20 mm proximal to the origin of the celiac artery.
|
Device: Talent Thoracic Stent Graft |
Registry
Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.
|
Device: Talent Thoracic Stent Graft |
High Risk
Patients that meet one or more of the following:
|
Device: Talent Thoracic Stent Graft |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
TEST GROUP Inclusion Criteria
Patient has a:
TEST GROUP Exclusion Criteria
Principal Investigator: | Mark Kaye, MD | Physician's Regional Medical Center |
Principal Investigator: | Phillip Allmendinger, MD | Hartford Hospital |
Principal Investigator: | Mark Bates, MD | CAMC Health System |
Principal Investigator: | Daniel Benckart, MD | Allegheny General Hospital |
Principal Investigator: | Paul Bove, MD | William Beaumont Hospitals |
Principal Investigator: | Thomas Bower, MD | Mayo Clinic |
Principal Investigator: | Alfio Carroccio, MD | Mt. Sinai School of Medicine |
Principal Investigator: | Neal Cayne, MD | NYU Vascular Associates |
Principal Investigator: | Frank Criado, MD | Union Memorial Hospital |
Principal Investigator: | Alan Matsumoto, MD | University of Virginia |
Principal Investigator: | Mark Eskandari, MD | Northwestern Memorial Hospital |
Principal Investigator: | Ronald Fairman, MD | University of Pennsylvania |
Principal Investigator: | Mark Farber, MD | University of North Carolina |
Principal Investigator: | James McKinsey, MD | New York Presbyterian (Columbia & Cornell) |
Principal Investigator: | Mark Fillinger, MD | Dartmouth-Hitchcock Medical Center |
Principal Investigator: | H. Edward Garrett, MD | Baptist Memorial Hospital |
Principal Investigator: | Marc Glickman, MD | Sentar Norfolk General |
Principal Investigator: | Kim Hodgson, MD | Memorial Medical Center |
Principal Investigator: | Matthew Jung, MD | Surgical Care Associates |
Principal Investigator: | Barry Katzen, MD | Baptist Hospital of Miami |
Principal Investigator: | Zvonimir Krajcer, MD | St. Luke's Episcopal Hospital-Houston |
Principal Investigator: | Christopher Kwolek, MD | Massachusetts General Hospital |
Principal Investigator: | Lowell Satler, MD | Washington Hospital Center |
Principal Investigator: | Anthony Lee, MD | University of Florida |
Principal Investigator: | Alan Lumsden, MD | Baylor College of Medicine |
Principal Investigator: | Sean Lyden, MD | Cleveland Clinic Foundation-Ohio |
Principal Investigator: | Richard McCann, MD | Duke University |
Principal Investigator: | Manish Mehta, MD | Vascular Group, PLLC |
Principal Investigator: | Mark Mewissen, MD | St. Luke's Vascular Center |
Principal Investigator: | Takao Ohki, MD | Montefiore Medical Center |
Principal Investigator: | Venkatesh Ramaiah, MD | Arizona Heart Institute |
Principal Investigator: | Robert Rhee, MD | Shadyside Hospital-UPMC |
Principal Investigator: | Timothy Roush, MD | Carolinas Medical Center |
Principal Investigator: | Gregoria Sicard, MD | Washington University School of Medicine |
Principal Investigator: | Cary Stowe, MD | Florida Hospital |
Principal Investigator: | Jim Swischuk, MD | Saint Francis Memorial Hospital |
Principal Investigator: | Michael Tuchek, MD | Loyola University |
Principal Investigator: | Rodney White, MD | Harbor UCLA |
Principal Investigator: | David Williams, MD | University of Michigan |
Principal Investigator: | Christopher Zarins, MD | Stanford University |
Responsible Party: | University of Pennsylvania ( Principal Investigator: Ronald Fairman, MD ) |
Study ID Numbers: | Investigational Plan #031 |
Study First Received: | December 21, 2007 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00604799 |
Health Authority: | United States: Food and Drug Administration |
Aortic Diseases Aortic Aneurysm, Thoracic Aneurysm Vascular Diseases Aortic Aneurysm |
Cardiovascular Diseases |