MedDataX Logo

VALOR: The Talent Thoracic Stent Graft System Clinical Study

NCT ID: NCT00604799

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Aortic Aneurysms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Talent Thoracic Stent Graft

Intervention Type DEVICE

TEVAR

Registry (Enrollment Completed)

Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.

Group Type OTHER

Talent Thoracic Stent Graft

Intervention Type DEVICE

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

Group Type OTHER

Talent Thoracic Stent Graft

Intervention Type DEVICE

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.

Group Type OTHER

Talent Thoracic Stent Graft

Intervention Type DEVICE

TEVAR

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Talent Thoracic Stent Graft

TEVAR

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Kaye, MD

Role: PRINCIPAL_INVESTIGATOR

Physician's Regional Medical Center

Phillip Allmendinger, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Mark Bates, MD

Role: PRINCIPAL_INVESTIGATOR

CAMC Health System

Daniel Benckart, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Paul Bove, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Thomas Bower, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Alfio Carroccio, MD

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai School of Medicine

Neal Cayne, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Vascular Associates

Frank Criado, MD

Role: PRINCIPAL_INVESTIGATOR

Union Memorial Hospital

Alan Matsumoto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Mark Eskandari, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital

Ronald Fairman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Mark Farber, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

James McKinsey, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian (Columbia & Cornell)

Mark Fillinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

H. Edward Garrett, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Memorial Hospital

Marc Glickman, MD

Role: PRINCIPAL_INVESTIGATOR

Sentar Norfolk General

Kim Hodgson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Medical Center

Matthew Jung, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical Care Associates

Barry Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health South Florida

Zvonimir Krajcer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Episcopal Hospital-Houston

Christopher Kwolek, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Lowell Satler, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Anthony Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Alan Lumsden, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Sean Lyden, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Foundation-Ohio

Richard McCann, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Manish Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Group, PLLC

Mark Mewissen, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Vascular Center

Takao Ohki, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Venkatesh Ramaiah, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Heart Institute

Robert Rhee, MD

Role: PRINCIPAL_INVESTIGATOR

Shadyside Hospital-UPMC

Timothy Roush, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Gregoria Sicard, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Cary Stowe, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Jim Swischuk, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Michael Tuchek, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Rodney White, MD

Role: PRINCIPAL_INVESTIGATOR

Harbor UCLA

David Williams, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Christopher Zarins, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Investigational Plan #031

Identifier Type: -

Identifier Source: org_study_id