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Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal)

2014-08-27 03:35:28 | BioPortfolio

Summary

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, implantable endoluminal vascular device preloaded in a placement system that is used to exclude abdominal aortic aneurysms.

Description

An aneurysm is a localized dilatation of a blood vessel at least 1 1/2 to 2 times the normal vessel diameter. Abdominal aortic aneurysms are relatively common, and have been detected in 1.3% to 2.7% of patients 65 to 80 years of age (Blum, et al, 1996; Collins, Araujo, and Lindsell, 1988; Scott, Ashton, and Kay, 1991). A large proportion (up to 50%) of patients with untreated AAAs experience rupture and exsanguination (Johansen, 1995). Ruptured AAAs are the 13th leading cause of death in the US, accounting for more than 15,000 deaths per year (Cronenwett and Sampson, 1995).

Conventional treatment of abdominal aortic aneurysms is by a surgical procedure involving midline laparotomy, aortic clamping, aortic bypass, and blood loss with associated transfusion. Improvements in surgical techniques and patient care have allowed the mortality rate associated with this procedure to be reduced to approximately 5%, when elective repair is done prior to rupture of the aneurysm. Risks of surgery increase when the patient is considered to be a poor candidate for surgery.

Due to progress made in interventional radiology and endovascular surgery, it is now possible to treat aneurysms without an abdominal surgical procedure, thus potentially further reducing the risks associated with elective repair. This new therapeutic approach consists of transfemoral introduction of a metallic stent coupled with a vascular graft. When the stent device is deployed and expanded within the aneurysmal blood vessel, it creates a new aortic lumen for blood flow, effectively excluding the aneurysm sac from the flow while maintaining perfusion to the lower limbs. This less invasive technique is designed to prevent the need for laparotomy, to reduce the need for blood transfusions, to decrease the use of anesthetics and other drugs, and to speed recovery time.

The objective of this study is to evaluate the safety and effectiveness of the TALENT endoluminal stent-graft system in patients who may be categorized as standard risk, high risk or other indications. Standard risk patients are patients with indications for treatment that are consistent with those for a manufacturer IDE, when there is no active enrollment in the IDE. High risk patients are patients who do not meet the entrance criteria for the manufacturer sponsored IDE as they are at high risk of morbidity and mortality with standard surgical repair. Other indications would be considered patients with indications for treatment outside of those or the manufacturer sponsored IDE.

This study will be performed in both high risk and low risk patients who are considered good candidates for endoluminal repair of abdominal aortic aneurysms. Patients should be heparinized during the implant procedure such that an activated clotting time of 300 seconds is achieved. During implantation of the TALENT endoluminal stent-graft, the pre-implant CT scan and available angiograms are used together with (on-the-table) digital subtraction angiography (DSA), roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) 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 push rod is held stationary while the outer sheath is slowly withdrawn. The introducer sheath is then withdrawn further until the stent-graft is completely deployed. The balloon may be inflated 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 TALENT 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 abdominal 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 Examination, Bilateral ABIs, and a Duplex Ultrasound (if not previously completed at time of discharge). Subject evaluation at 6 months will also include a Complete Physical Examination, Bilateral ABIs, Duplex Ultrasound, and Abdominal X-ray (AP, Lateral, 2 Obliques). Subject evaluation at 12, 24, 36, 48, and 60 months will include a Complete Physical Examination, Bilateral ABIs, Abdominal X-ray (AP, Lateral, 2 Obliques), and Spiral CT scan with and without IV Contrast 2.5mm.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Abdominal Aortic Aneurysm

Intervention

TALENT Enhanced LPS Endoluminal Stent-Graft System

Location

Arizona Heart Institute
Phoenix
Arizona
United States
85006

Status

Active, not recruiting

Source

Arizona Heart Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:35:28-0400

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Medical and Biotech [MESH] Definitions

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.

An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.

Small masses of chromaffin cells found near the SYMPATHETIC GANGLIA along the ABDOMINAL AORTA, beginning cranial to the superior mesenteric artery (MESENTERIC ARTERY, SUPERIOR) or renal arteries and extending to the level of the aortic bifurcation or just beyond. They are also called the organs of Zuckerkandl and sometimes called aortic bodies (not to be confused with AORTIC BODIES in the THORAX). The para-aortic bodies are the dominant source of CATECHOLAMINES in the FETUS and normally regress after BIRTH.

Small clusters of chemoreceptive and supporting cells located near the ARCH OF THE AORTA; the PULMONARY ARTERIES; and the coronary arteries. The aortic bodies sense PH; CARBON DIOXIDE; and oxygen concentrations in the BLOOD and participate in the control of RESPIRATION. The aortic bodies should not be confused with the PARA-AORTIC BODIES in the abdomen (which are sometimes also called aortic bodies).

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

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