VALOR: The Talent Thoracic Stent Graft System Clinical Study (VALOR)

Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysms
• Intervention / Treatment: Device: Talent Thoracic Stent Graft

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Christopher Kwolek, MD, Massachusetts General Hospital; 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: James McKinsey, MD, New York Presbyterian (Columbia & Cornell); 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: Lowell Satler, MD, MedStar Health Research Institute; 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: 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, AdventHealth; 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

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: Investigational Plan #031