Valor II: The Valiant Thoracic Stent Graft System Clinical Study - Full Text View

Sponsored by:	Medtronic Endovascular
Information provided by:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00413231

Purpose

The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.

Condition	Intervention
Thoracic Aortic Aneurysm	Device: Stent Graft

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

Successful aneurysm treatment at 12 mo. follow-up is the absence of both: Aneurysm growth that is > or = to 5 mm at the 12 mo. visit relative to the 1 mo. visit. Type I and/or Type III endoleak where a secondary procedure was performed or recommended.

Secondary Outcome Measures:

Will evaluate the percentage of patients that experience adverse events within 30 days and 12 months after treatment, successful implantation of the device and health care utilization
The secondary endpoints will be evaluated all time points in the study will also be evaluated at all the follow-up intervals over 5 years.

Estimated Enrollment:	150
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2012

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Subject is between the age of 18 and 85.
Subject must be considered a candidate for elective surgical repair of the thoracic aortic aneurysm (i.e., low-to-moderate risk at the time of implant.
If Subject is female of childbearing potential she must have a negative pregnancy test within 7 days befor0e the implanting procedure.
Subject has a Descending Thoracic Aneurysm that is: with a maximum diameter of 5 cm or larger; or is > 2 times the diameter of the non-aneurysmal thoracic aorta; or
Subject's anatomy must meet the protocol parameters
Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within the previous four (4) months prior to screening.
Subject is able and willing to comply with the protocol and undergo follow-up requirements.
Subject or Subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.

Exclusion:

History of thoracic aneurysm with a contained rupture.
History of connective tissue disease
Systemic infection
Previous stent or stent graft or previous surgical repair in the descending thoracic aorta.
History of treatment of an infra-renal aneurysm
History of bleeding
Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft System implantation. This does not include planned procedures that are needed for the safe and effective placement of the stent graft.(i.e., carotid/subclavian transposition, bypass procedure).
Subject has had a recent MI or cerebral vascular accident (CVA) (within 3 months).
Subject is currently participating in an investigational drug or device clinical trial.
Subject has a known allergy or intolerance to the device components.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413231

Contacts

Contact: Simona Zannetti, MD, Director of Clinical Affairs

simona.zannetti@medtronic.com

Show 26 Study Locations

Sponsors and Collaborators

Medtronic Endovascular

Investigators

Principal Investigator:

Ronald Fairman, MD

University of Pennsylvania

More Information

No publications provided

Study ID Numbers:	Investigational Plan #078
Study First Received:	December 15, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00413231 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

Thoracic Aneurysm
Endovascular Aortic REpair (EVAR)
Endovascular Stent Graft
Endograft

Thoracic Aortic Aneurysm
Endovascular procedure
Descending Thoracic Aneurysm

Study placed in the following topic categories:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on May 07, 2009