Clinical Study of Thoracic Aortic Aneurysm Exclusion
The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and both traumatic and degenerative pseudoaneurysms.
A vascular aneurysm is a permanent, localized dilatation of a blood vessel at least 1 1/2 to 2 times the normal vessel diameter. The aorta is the most frequent site for aneurysms, with approximately 10% of aortic aneurysms located above the renal arteries in the thoracic segment. Thoracic aortic aneurysms (TAAs) are less common than abdominal aorta, however, detection of TAAs is increasing, perhaps due to an aging population, increased diagnostic capability or an increase in prevalence.
Untreated thoracic aneurysms can be life-threatening. As many as 78% of untreated patients with TAA die within 5 years after diagnosis, most often from rupture of the aneurysm. Conventional surgical treatment, either tube graft placement or patch aortoplasty, is a high risk surgical procedure. Repair of the thoracic descending aorta is performed with a thoracotomy and cross-clamping of the aorta, with or without a shunt by-pass to maintain distal perfusion.
As an alternative to conventional surgery, a less invasive endovascular procedure has been developed that may be used to treat certain aneurysms. A collapsed stent-graft, a metal stent coupled with a fabric graft, is introduced into the vasculature, advanced to the size of the aneurysm, and deployed to span the aneurysm. The device creates a new aortic lumen, excluding the aneurysm sac from blood flow while maintaining flow within the stent-graft. This less invasive technique is designed to prevent or decrease the need for open surgery, to reduce the need for blood transfusion, to decrease the use of anesthetics and other drugs, and to speed recovery time. A reduction in intensive care and total hospital stay should result, leading to an increase quality of life following the procedure and a reduction in cost.
The primary objective of this investigational plan is to determine the safety of the Valiant endoluminal device when used to exclude thoracic lesions: true descending thoracic aortic aneurysms, dissections, penetrating ulcers, traumatic transections and traumatic and degenerative pseudoaneurysms from blood flow in high risk and low risk patients who are candidates for endoluminal repair.
Patients should be heparinized during the implant procedure (recommended activated clotting time is 200-300 seconds). During implantation of the Valiant endoluminal stent-graft, the pre-implant angiogram and CT scan are used together with (on-the-table) intravascular ultrasound (IVUS), digital subtraction angiography (DAS), roadmapping, and angiography for proper implant positioning. The Valiant endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The introducer sheath and delivery catheter containing the stent-graft is inserted over a guidewire and advanced into the aorta and above the aneurysm. With the delivery catheter in the correct position, the introducer sheath is then withdrawn further until the stent-graft is completely deployed. A separate stent-graft balloon catheter system is provided with the device and may be used along the full length of the implanted device to model the springs against the vessel wall and to unravel possible wrinkles in the graft fabric. After deployment of the stent-graft, angiography is performed to verify implant position and to check for the presence of endoleaks.
Subjects will undergo an evaluation of the Valiant endoluminal stent-graft to determine the safety and efficacy of the device as indicated by the adverse event rate, and to determine the risk factors that are most predictive of a successful outcome when used to exclude thoracic aortic aneurysms that require suprarenal fixation in high risk and low risk patients. Follow-up will be completed at 1, 6, 12, 24, 36, 48, and 60 months. Subject evaluation at 1 month will include a Complete Physical Exam, Labs (BUN and Creatinine), and a Thoracic Spiral CT with and without IV contrast 2.5 mm. Subject evaluation at 6, 12, 24, 36, 48, and 60 months will include a Complete Physical Exam, Chest X-ray (AP, Lateral), Labs (BUN and Creatinine), and a Thoracic Spiral CT with and without IV contrast 2.5 mm.
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Thoracic Aortic Aneurysm
Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter
Arizona Heart Institute
Arizona Heart Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00549315
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Host Vs Graft Reaction
The immune responses of a host to a graft. A specific response is GRAFT REJECTION.
Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.
Graft Vs Host Reaction
An immunological attack mounted by a graft against the host because of tissue incompatibility when immunologically competent cells are transplanted to an immunologically incompetent host; the resulting clinical picture is that of GRAFT VS HOST DISEASE.
The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host.
Graft Enhancement, Immunologic
The induction of prolonged survival and growth of allografts of either tumors or normal tissues which would ordinarily be rejected. It may be induced passively by introducing graft-specific antibodies from previously immunized donors, which bind to the graft's surface antigens, masking them from recognition by T-cells; or actively by prior immunization of the recipient with graft antigens which evoke specific antibodies and form antigen-antibody complexes which bind to the antigen receptor sites of the T-cells and block their cytotoxic activity.
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has...
The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible, impl...
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall...
This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
In western countries, the use of a balloon-expandable covered stent is recommended for the treatment of native coarctation of the aorta (CoA) in adult patients because endovascular bare stents cannot...
Entrapment of an intravascular ultrasonography (IVUS) catheter is an infrequent but serious complication associated with percutaneous coronary intervention (PCI). A 67-year-old man who presented with...
The aim of the present article is to describe a new thoracic stent graft (Zenith TX2 Low-Profile TAA Endovascular Graft).
A 72-year-old woman who had a patent ductus arteriosus that was anatomically unsuitable for catheter coiling was treated with a pre-curved fenestrated stent graft. This graft was custom-made to config...
One of the technical limitations of surgeon-modified fenestrated stent grafts is the lack of a diameter-reducing wire, which facilitates catheterization of target branches if there are errors of devic...