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

Thoracic Aortic Dissection Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 experimental treatment. During this time, the patient will have several tests performed to evaluate the function of the repair. The tests will include clinical examination, x-rays of the chest and spiral CT scan. The experimental part is the placement of the TALENT Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental catheter bypasses is that the procedure may not be successful. In most cases, this would require a standard operation to repair the problem. Sometimes there are other risks such as injury to the vessels. Small pieces of diseased arteries may be dislodged which may require removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a catheter bypass is unsuccessful, there can be added discomfort because the procedure may last longer.

The benefits of the procedure are that the patient might avoid some of of the pain and discomfort associated with standard operations. Major surgery is avoided and hospital stay may be much shorter. Patients may be able to return to usual daily activities sooner. In addition, patients who are too high risk for conventional surgical treatment can have their aneurysm treated using the endovascular graft if their anatomy is appropriate ;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Dissection
• Hematoma
• Intramural Hematoma
• Pseudoaneurysm
• Thoracic Aortic Aneurysms
• Thoracic Aortic Dissection
• Thoracic Transections

• NCT number: NCT00597870
• Study type: Interventional
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Completion date: January 2021