Continuous Infra-Inguinal Stenting Using the FlexStar and FlexStar XL Ultra Long Metallic Self-Expanding Stent Systems
Summary
To collect both pre-market and post-market confirmatory evidence of the safety and effectiveness of the LifeStent Self-Expanding Stent System in patients with de novo and restenotic (non-stented) lesion(s) in the infra-inguinal (SFA and Popliteal) arteries.
Description
The purpose of the study is to collect both pre-market and post-market confirmatory evidence of the safety and effectiveness of the LifeStent Self-Expanding Stent System in patients with de novo and restenotic (non-stented) lesion(s) in the infra-inguinal (SFA and Popliteal) arteries.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
SFA Disease
Intervention
PTA followed by the LifeStent Self-Expanding Stent System
Status
Not yet recruiting
Source
C. R. Bard
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00908947
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Whipple Disease
A chronic systemic infection by a gram-positive bacterium, Tropheryma whippelii, mainly affecting the SMALL INTESTINE but also the JOINTS; CARDIOVASCULAR SYSTEM; and the CENTRAL NERVOUS SYSTEM. The disease is characterized by fat deposits in the INTESTINAL MUCOSA and LYMPH NODES, malabsorption, DIARRHEA with fatty stools, MALNUTRITION, and ARTHRITIS.
Neointima
The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.
Ostomy
Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.
Lyme Disease
An infectious disease caused by a spirochete, BORRELIA BURGDORFERI, which is transmitted chiefly by Ixodes dammini (see IXODES) and pacificus ticks in the United States and Ixodes ricinis (see IXODES) in Europe. It is a disease with early and late cutaneous manifestations plus involvement of the nervous system, heart, eye, and joints in variable combinations. The disease was formerly known as Lyme arthritis and first discovered at Old Lyme, Connecticut.
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.
Clinical Trials
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PubMed Articles
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BACKGROUND: The clinical differences between side-by-side and stent-in-stent deployment using a self-expanding metal stent for hilar malignant obstruction have not been evaluated. AIMS: The purpose of...
BACKGROUND: The acute impact in vivo from a selfexpanding stent on the vessel wall has not been sufficiently evaluated. OBJECTIVES: We sought to compare acute in vivo injury on the vessel wall and the...
