Overview

This trial is active, not recruiting.

Condition thoracic aortic aneurysm
Treatment valiant thoracic stent graft system
Sponsor Medtronic Endovascular
Start date December 2006
End date August 2010
Trial size 160 participants
Trial identifier NCT00413231, Investigational Plan #078

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Primary Effectiveness Endpoint: Percentage of Participants With Successful Aneurysm Treatment.
time frame: At 12-month post procedure
Primary Safety Endpoint: All-Cause Mortality. > > The Percentage of Participants Who Died of All Causes.
time frame: Within 12-months post treatment

Secondary Outcomes

Measure
Secondary Endpoints, Within 30 Days Post Treatment
time frame: within 30 days post treatment
Secondary Endpoints, Within 12 Months Post Treatment
time frame: Within 12 months post treatment
Successful Deployment and Delivery of the Stent Graft
time frame: N/A (at implant)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion: - 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.

Additional Information

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.
Principal investigator Ronald Fairman, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.