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Aorfix Intelliflex First in Human Study

2016-09-20 20:38:21 | BioPortfolio

Summary

The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Aortic Aneurysm, Abdominal

Intervention

Endovascular aneurysm repair EVAR

Status

Active, not recruiting

Source

Lombard Medical

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-20T20:38:21-0400

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PubMed Articles [4928 Associated PubMed Articles listed on BioPortfolio]

Survival and Re-intervention Risk by Patient Age and Preoperative Abdominal Aortic Aneurysm (AAA) Diameter Following Endovascular Aneurysm Repair (EVAR).

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To compare the treatment outcomes and cost of endovascular aortic aneurysm repair (EVAR) and open surgical repair (OSR) in patients with an abdominal aortic aneurysm (AAA) at a single center.

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Endovascular aneurysm repair (EVAR) is used increasingly in the management of patients with abdominal aortic aneurysms (AAAs), including in the emergency setting for ruptured AAA. The lower mortality ...

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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.

The tearing or bursting of the wall along any portion of the AORTA, such as thoracic or abdominal. It may result from the rupture of an aneurysm or it may be due to TRAUMA.

Aneurysm due to growth of microorganisms in the arterial wall, or infection arising within preexisting arteriosclerotic aneurysms.

Solitary lesions of bone that typically cause a bulging of the overlying cortex bearing some resemblance to the saccular protrusion of the aortic wall in aortic aneurysm, hence the name. (Dorland, 27th ed)

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