The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis
Summary
The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled hypertension.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
Description
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Renal Artery Obstruction
Intervention
Herculink Elite Renal Stent System
Location
Charleston Area Medical Center
Charleston
West Virginia
United States
25301
Status
Active, not recruiting
Source
Abbott Vascular
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00490841
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Renal Artery Obstruction
Narrowing or occlusion of the RENAL ARTERY or arteries. It is due usually to ATHEROSCLEROSIS; FIBROMUSCULAR DYSPLASIA; THROMBOSIS; EMBOLISM, or external pressure. The reduced renal perfusion can lead to renovascular hypertension (HYPERTENSION, RENOVASCULAR).
Pyonephrosis
Distention of KIDNEY with the presence of PUS and suppurative destruction of the renal parenchyma. It is often associated with renal obstruction and can lead to total or nearly total loss of renal function.
Urinoma
An encapsulated accumulation of URINE in the retroperitoneal area. It has the appearance of a cyst (CYSTS). Urinoma is usually caused by URETERAL OBSTRUCTION, renal trauma or perforation of the renal collecting system.
Hypertension, Renovascular
Hypertension due to RENAL ARTERY OBSTRUCTION or compression.
Renal Plasma Flow
The amount of PLASMA that perfuses the KIDNEYS per unit time, approximately 10% greater than effective renal plasma flow (RENAL PLASMA FLOW, EFFECTIVE). It should be differentiated from the RENAL BLOOD FLOW; (RBF), which refers to the total volume of BLOOD flowing through the renal vasculature, while the renal plasma flow refers to the rate of plasma flow (RPF).
Clinical Trials
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.
Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis
Background: Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Cur...
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atheros...
Renal Fractional Flow Reserve in Renal Artery Stenting
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.
Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years. The purpose of the study is to evaluate th...
PubMed Articles
Renal denervation in a patient with prior renal artery stenting.
This is a case report of a 69 year-old female with treatment-resistant severe arterial hypertension despite prior successful percutaneous intervention to both renal arteries for significant renal arte...
When renal artery occlusion occurs secondary to blunt trauma, the recovery rate of renal function after open revascularization is varied and far from satisfactory. Although the optimal treatment for t...
Case 1. The Distressed Health Care Provider Mr MF was a 72 yo married father living independently with his wife. Mr MF was admitted electively for non-operative correction of a known left renal artery...
Two-stent strategy for renal artery stenosis with bifurcation lesion.
Renal artery stenosis (RAS) with a bifurcation lesion is a challenge for interventional therapy. The aim of this study is to summarize our experience in RAS with a bifurcation lesion. Five patients wi...
Mycotic aneurysms are uncommon, especially those located in visceral arteries. We present a case of a patient with two visceral mycotic aneurysms due to bacterial endocarditis, one located in right up...
