Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Summary
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-iliac Aneurysms.
Description
Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Abdominal Aortic Aneurysms
Intervention
Endurant Stent Graft System, Endurant Stent Graft System
Location
University of Alabama Hospitals
Birmingham
Alabama
United States
35294
Status
Recruiting
Source
Medtronic Endovascular
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00705718
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
Graft Vs Host Disease
The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.
Clinical Trials
Endurant Stent Graft Natural Selection Global Postmarket Registry
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
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 Vascutek AnacondaTM Stent Graft System Phase II IDE Study
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of...
Clinical Study of Thoracic Aortic Aneurysm Exclusion
The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic a...
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...
PubMed Articles
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...
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...
Zenith® TX2®LowProfile TAA Endovascular Graft: a next generation thoracic stent-graft.
The aim of the present article is to describe a new thoracic stent graft (Zenith TX2 Low-Profile TAA Endovascular Graft).
Technique of Adding a Diameter-reducing Wire to the Modified TX2 Fenestrated Stent Graft.
One of the technical limitations of surgeon-modified fenestrated stent grafts is the lack of a diameter-reducing wire, which facilitates catheterization of target branches if there are errors of devic...
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...
