Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
Summary
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 the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Renal Artery Stenosis
Intervention
Dynamic Renal Stent plus Best Medical Treatment, Best Medical Treatment
Location
Herzzentrum Bad Krozingen
Bad Krozingen
Baden-Württemberg
Germany
79189
Status
Recruiting
Source
Biotronik AG
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00640406
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Emergency Treatment
First aid or other immediate intervention for accidents or medical conditions requiring immediate care and treatment before definitive medical and surgical management can be procured.
Medical Futility
The absence of a useful purpose or useful result in a diagnostic procedure or therapeutic intervention. The situation of a patient whose condition will not be improved by treatment or instances in which treatment preserves permanent unconsciousness or cannot end dependence on intensive medical care. (From Ann Intern Med 1990 Jun 15;112(12):949)
Medical Tourism
Travel to another country for the purpose of medical treatment.
Emergency Medicine
The branch of medicine concerned with the evaluation and initial treatment of urgent and emergent medical problems, such as those caused by accidents, trauma, sudden illness, poisoning, or disasters. Emergency medical care can be provided at the hospital or at sites outside the medical facility.
Baths
The immersion or washing of the body or any of its parts in water or other medium for cleansing or medical treatment. It includes bathing for personal hygiene as well as for medical purposes with the addition of therapeutic agents, such as alkalines, antiseptics, oil, etc.
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