VALOR: The Talent Thoracic Stent Graft System Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00604799
First received: December 21, 2007
Last updated: July 16, 2012
Last verified: July 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms

Resource links provided by NLM:


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. [ Time Frame: 12 months ] [ 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 379
Study Start Date: July 2003
Study Completion Date: June 2011
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test (Enrollment Completed)
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
TEVAR
Registry (Enrollment Completed)
Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.
Device: Talent Thoracic Stent Graft
TEVAR
High Risk (Enrollment Completed)

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
TEVAR
Talent Captivia (Recruiting)
Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.
Device: Talent Thoracic Stent Graft
TEVAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Talent Captivia Inclusion Criteria

  1. Patient is at least 18 years of age.
  2. Patient is a surgical or non-surgical candidate
  3. Patient has a:

    1. Fusiform focal TAA AND / OR
    2. Focal saccular TAA or penetrating atherosclerotic ulcer.
  4. Subject's anatomy must meet all of the following anatomical criteria:

    1. iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
    2. non-aneurysmal aortic diameter in the range of 18-42mm; and
    3. non-aneurysmal aortic proximal and distal neck lengths =/>20mm
  5. 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 the implant procedure.
  6. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
  7. Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia 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
  2. Pregnant female
  3. Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
  4. Patient has a mycotic aneurysm or is suspected of having systemic infection.
  5. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
  6. Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
  7. The patient has known allergy or intolerance to the device components.
  8. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  9. 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 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604799

Locations
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
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 West Penn Allegheny Health System
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 Health South Florida
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

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604799     History of Changes
Other Study ID Numbers: Investigational Plan #031
Study First Received: December 21, 2007
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 19, 2014