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VALOR: The Talent Thoracic Stent Graft System Clinical Study
This study has been completed.
Sponsored by: Medtronic Endovascular
Information provided by: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604799
  Purpose

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

MedlinePlus related topics: Aneurysms
U.S. FDA Resources
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

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit. [ Designated as safety issue: No ]
  • Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up. [ Designated as safety issue: Yes ]

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:

  • High Risk (SVS 3)
  • Non-surgical candidates not associated with SVS scoring
  • Traumatic thoracic injuries
Device: Talent Thoracic Stent Graft

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

TEST GROUP Inclusion Criteria

  1. Patient is between the ages of 18 and 85.
  2. Patient must be considered a candidate for elective surgical repair of the thoracic aortic aneurysm (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant; See Appendix A).
  3. Females of childbearing age must have a negative pregnancy test within 7 days before treatment.
  4. Patient has a:

    1. Fusiform focal TAA that is >5 cm in maximum diameter or is > 2 times the diameter of the adjacent native/non-aneurysmal aorta AND / OR
    2. Focal saccular TAA or penetrating atherosclerotic ulcer.
  5. Thoracic aortic aneurysm must be at least 20 mm distal to the origin of the left common carotid artery and must be at least 20 mm proximal to the origin of the celiac artery.
  6. Proximal and distal aortic non-aneurysmal neck diameter measurements must be > 18 mm and < 42 mm.
  7. Patient's vascular anatomy is suitable for placement of the Talent Thoracic Stent Graft by having distinct proximal and distal aneurysm neck of >20 mm in length.
  8. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to screening.
  9. Patient must be able and willing to undergo follow-up imaging and examinations at 1, 6, and 12 month follow-up periods and annually for a total of five (5) years from initial implant. Lifelong follow-up by the physician is required after patients have completed the study.

TEST GROUP Exclusion Criteria

  1. Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1 (See Figure 5; Due to potential deployment difficulties, positioning the proximal edge of the bare spring in an overly angulated portion of the aorta is not recommended.)
  2. The patient's access vessel (as determined by treating physician) precludes safe insertion of the delivery system.
  3. Patient requires a planned aortic conduit.
  4. Thoracic aneurysm with a contained rupture.
  5. Patient has a connective tissue disease (e.g., Marfan's syndrome, medial degeneration).
  6. Patient has a mycotic aneurysm or is suspected of having systemic infection.
  7. Patient has received a previous stent and/or stent graft or previous surgical repair in the descending thoracic aortic area.
  8. Patient requires treatment of an infra-renal aneurysm at the time of implant.
  9. Patient has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
  10. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
  11. Patient has undergone a vascular interventional procedure or major surgery 30 days prior to enrollment. NOTE: This does not include planned procedures that are needed for safe and effective placement of the stent graft (i.e. carotid/subclavian transpositions, bypass procedures).
  12. Patient requires a planned vascular interventional procedure or major surgery within 30 days of the implant procedure. NOTE: This does not include planned procedures that are needed for safe and effective placement of the stent graft (i.e. carotid/subclavian transpositions, bypass procedures).
  13. Patient has had a recent (within three (3) months) cerebral vascular accident (CVA).
  14. Patient is currently participating in an investigational drug or device clinical trial. (Patient must have completed the follow-up phase of any previous study at least 1 month prior to enrollment into this trial).
  15. The patient has a known allergy or intolerance to the device components.
  16. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  17. The presence of significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the implanted stent graft.
  18. The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than one year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604799

Sponsors and Collaborators
Medtronic Endovascular
Investigators
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
  More Information

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

Study placed in the following topic categories:
Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009