VALOR: The Talent Thoracic Stent Graft System Clinical Study

NCT00604799 | Completed Phase 2 DMC

• 1 other identifier: Investigational Plan #031
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Aortic Aneurysms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Test (Enrollment Completed)

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 (Enrollment Completed)

OTHER

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 (Enrollment Completed)

OTHER

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

Talent Captivia (Recruiting)

OTHER

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

Interventions

Talent Thoracic Stent Graft DEVICE

TEVAR

High Risk (Enrollment Completed); Registry (Enrollment Completed); Talent Captivia (Recruiting); Test (Enrollment Completed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years of age.
• Patient is a surgical or non-surgical candidate
• Patient has a:
• Fusiform focal TAA AND / OR
• Focal saccular TAA or penetrating atherosclerotic ulcer.
• Subject's anatomy must meet all of the following anatomical criteria:
• iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
• non-aneurysmal aortic diameter in the range of 18-42mm; and
• non-aneurysmal aortic proximal and distal neck lengths =/\>20mm
• 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.
• Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
• Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

You may not qualify if:

• Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
• Pregnant female
• Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
• Patient has a mycotic aneurysm or is suspected of having systemic infection.
• Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
• Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
• The patient has known allergy or intolerance to the device components.
• The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• 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

  Corewell Health East

  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

  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

• 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

  AdventHealth

  PRINCIPAL INVESTIGATOR

• Jim Swischuk, MD

  Saint Francis 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 30, 2008
• Study Start: July 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2011
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)