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Endurant Stent Graft Natural Selection Global Postmarket Registry

18:23 EDT 21st May 2013 | BioPortfolio

Summary

The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Description

The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Aortic Aneurysm, Abdominal

Intervention

Endurant Stent Graft

Location

The Queen Elizabeth Hospital
Adelaide
Australia
SA 5011

Status

Recruiting

Source

Medtronic Bakken Research Center

Results (where available)

View Results

Links

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.

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.

Bone Cysts, Aneurysmal

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)

Clinical Trials [ 954 Associated Clinical Trials listed on BioPortfolio]

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-iliac 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...

Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal)

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, impl...

Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operat...

PubMed Articles [ 8124 Associated PubMed Articles listed on BioPortfolio]

The Endurant Stent Graft System: 15-month follow-up report in patients with challenging abdominal aortic anatomies.

OBJECTIVE: The objective of this study is to report a 15-month follow-up with the Endurant Stent Graft System in patients with challenging aortic anatomies. METHODS: At three German clinics, a consecu...

Rationale and design of the Endurant Stent Graft Na-tural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled.

AIM: The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1200-patient multicenter prospective study initiated to augment the knowledge base (poolable and comp...

Early aortic endograft failure in the presence of periaortic lymphadenopathy with neurofibromatosis (von Recklinghausen's disease).

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...

Three-year Follow-up of Fenestrated Thoracoabdominal Stent Graft Bridging an Endovascular Thoracic Stent Graft and a Surgical Abdominal Aortic Graft.

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...

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