Clinical Trial: Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

Brief Summary: The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.

Detailed Summary:

The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into the diseased blood vessel without the need for major surgery which involves opening the chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an artificial bypass tube (stent graft) that will be placed inside the diseased artery. The stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa California.

Aneurysms/lesions can be located in any position along the length of the aorta. This study evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as it traverses the chest and enters the abdominal cavity. The risk of thoracic aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the aneurysm size increases. Following rupture, almost all patients expire within the first 24 hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional surgical means if the patient is a candidate for an operation. The conventional operation involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is part of the conventional surgery is directly related to several complications that have been reported in the literature. In addition, many patients are too ill for conventional surgery due to concomitant illnesses.

After the procedure, the patient will be followed at regular intervals (pre-discharge, 1 month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of the
Sponsor: Rodney A. White, M.D.

Current Primary Outcome: The primary objective of this investigational plan is to determine the safety of the Medtronic/Talent device when used to exclude thoracic lesions: true descending thoracic aortic aneurysms, dissections, penetrating ulcers, traumatic transections. [ Time Frame: open ]

Original Primary Outcome:

Current Secondary Outcome: To determine the proportion of patients who experience adverse events during and after the implantation procedure, including comorbidities and overall mortality rates. [ Time Frame: open ]

Original Secondary Outcome:

Information By: Los Angeles Biomedical Research Institute

Date Received: December 28, 2007
Date Started: May 2002
Date Completion: January 2020
Last Updated: September 7, 2016
Last Verified: September 2016