ARBITER-II: AorfixTM Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
Summary
To assess the safety and performance of AorfixTM Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.
Description
The AorfixTM Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is <65o. The objective of this study is to evaluate the safety and performance of the bifurcated AorfixTM Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated > 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication.
The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.
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 Aortic Aneurysm
Intervention
AorfixTM Stent Grafts (AAA endovascular procedure)
Location
2 Interni Klinika; General University Hospital
Prague
Czech Republic
12800
Status
Active, not recruiting
Source
Lombard Medical
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00442065
- 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.
Aortic Aneurysm, Abdominal
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.
Atherectomy
Endovascular procedure in which atheromatous plaque is excised by a cutting or rotating catheter. It differs from balloon and laser angioplasty procedures which enlarge vessels by dilation but frequently do not remove much plaque. If the plaque is removed by surgical excision under general anesthesia rather than by an endovascular procedure through a catheter, it is called ENDARTERECTOMY.
Aortic Rupture
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.
Syphilis, Cardiovascular
Cardiovascular manifestations of SYPHILIS, an infection of TREPONEMA PALLIDUM. In the late stage of syphilis, sometimes 20-30 years after the initial infection, damages are often seen in the blood vessels including the AORTA and the AORTIC VALVE. Clinical signs include syphilitic aortitis, aortic insufficiency, or aortic ANEURYSM.
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