AneuRx PostMarket Study
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. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair.
The purpose of this study is to monitor the long term performance of the AneuRX Stent Graft Systems.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Abdominal Aneurysm
Intervention
Stent Graft (AneuRX Stent Graft Systems)
Location
Tucson
Arizona
United States
Status
Completed
Source
Medtronic Endovascular
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00604552
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Endoleak
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.
Host Vs Graft Reaction
The immune responses of a host to a graft. A specific response is GRAFT REJECTION.
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.
Graft Survival
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.
Clinical Trials
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treat...
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms...
This study is a prospective observational study which will examine the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysm...
The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center an...
Clinical Study of the TriVascular Abdominal Stent Graft System
The primary objectives of this study are to determine whether the TriVascular AAA Stent Graft is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patient...
PubMed Articles
This case report describes repair of a type I endoleak at the distal landing zone of a thoracic aortic stent graft by endovascular placement of a thoracoabdominal fenestrated stent graft (Cook, Brisba...
Current knowledge on E-vita abdominal endograft.
The field of endovascular abdominal aortic repair has changed remarkably compared to what it was prior to 1993, the year of the first commercial endograft deployment in the United States. Over the yea...
An aortic stent graft is frequently used to cure an abdominal aortic aneurysm (AAA). It is critical to accurately fit the size and shape of the stent graft to the target region on the aorta. Proper si...
Aortic Stent-Graft for a Giant Bronchial Artery Aneurysm with Ultrashort Neck.
Bronchial artery aneurysms are rarely encountered, but they can cause life-threatening hemorrhages when they rupture. The authors report a case of a giant bronchial artery aneurysm with ultrashort nec...
A 78-year-old man with a history of neurofibromatosis was transferred to our hospital for treatment of an abdominal aortic aneurysm. T The patient was treated by stent graft implantation and was disch...