Clinical trial NCT00604799: VALOR: The Talent Thoracic Stent Graft System Clinical Study
Official title: Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Thoracic Aortic Aneurysms
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Physician's Regional Medical Center
name: Mark Kaye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford Hospital
name: Phillip Allmendinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMC Health System
name: Mark Bates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Penn Allegheny Health System
name: Daniel Benckart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospitals
name: Paul Bove, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Thomas Bower, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mt. Sinai School of Medicine
name: Alfio Carroccio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Vascular Associates
name: Neal Cayne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Memorial Hospital
name: Frank Criado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Alan Matsumoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Memorial Hospital
name: Mark Eskandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Ronald Fairman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Mark Farber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian (Columbia & Cornell)
name: James McKinsey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Mark Fillinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Memorial Hospital
name: H. Edward Garrett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentar Norfolk General
name: Marc Glickman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Medical Center
name: Kim Hodgson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgical Care Associates
name: Matthew Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Health South Florida
name: Barry Katzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Episcopal Hospital-Houston
name: Zvonimir Krajcer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Christopher Kwolek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Lowell Satler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Anthony Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Alan Lumsden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Foundation-Ohio
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Richard McCann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular Group, PLLC
name: Manish Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Vascular Center
name: Mark Mewissen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Takao Ohki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Institute
name: Venkatesh Ramaiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shadyside Hospital-UPMC
name: Robert Rhee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Medical Center
name: Timothy Roush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Gregoria Sicard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth
name: Cary Stowe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Francis Hospital
name: Jim Swischuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University
name: Michael Tuchek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor UCLA
name: Rodney White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: David Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Christopher Zarins, MD
role: PRINCIPAL_INVESTIGATOR
References: