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AneuRx PostMarket Study

05:20 EDT 23rd April 2014 | BioPortfolio

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)

View Results

Links

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.

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

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.

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 [1451 Associated Clinical Trials listed on BioPortfolio]

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 (PIVOTAL) Study

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...

A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of 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...

Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

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 [7085 Associated PubMed Articles listed on BioPortfolio]

Aorfix™ device for abdominal aortic aneurysm with challenging anatomy.

Anatomical characteristics of abdominal aortic aneurysms (AAA) are the most critical factors for successful endovascular aortic repair (EVAR). Of these, severe proximal aortic neck angulation and ilia...

Endovascular Repair of Abdominal Aortic Aneurysm using Bifurcated Stent-graft in a Patient with Complete Occlusion from the Common to the External Iliac Artery.

Extensive iliofemoral occlusive disease can limit the use of endovascular aortic aneurysm repair (EVAR), and the treatment strategy varies depending on severity of the lesion. In cases of mild iliac a...

Hybrid endovascular repair of a dissecting thoracoabdominal aortic aneurysm with stent graft implantation through the false lumen.

We report the first successful hybrid endovascular technique for treating a residual dissecting thoracoabdominal aortic aneurysm with a compressed true lumen in a 48-year-old man in whom multiple sten...

New possibility of AAA treatment with E-vita abdominal device.

The most dramatic shift in the management of abdominal aortic aneurysms (AAAs) occurred in 1991, when the first endovascular AAA repair was reported. Endovascular aneurysm repair has revolutionized th...

Technical feasibility of endovascular aortoiliac aneurysm repair combining Anaconda fenestrated and Zenith iliac side-branched stent grafts.

We demonstrate for the first time the technical feasibility of total endovascular aneurysm repair for juxtarenal and pararenal aortoiliac aneurysms by combining the Vascutek Anaconda custom-made fenes...

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