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Sponsors and Collaborators: |
Charite University, Berlin, Germany IKKF GmbH IHF Ludwigshafen Cordis Med. Apparate GmbH Boston Scientific Corporation |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00866398 |
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.
The study "Economic Evaluation of the German Drug-Eluting Stent Registry" examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis.
The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis.
Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.
Condition |
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Coronary Heart Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Economic Evaluation German Drug-Eluting Stent Registry |
Enrollment: | 3973 |
Study Start Date: | December 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1 DES
Patients receiving drug-eluting stent
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2 BMS
Patients receiving bare metal stent
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with coronary heart disease, eligible for stent implantation.
Inclusion Criteria:
Additional inclusion criteria BMS cohort:
Study Director: | Stefan N Willich, Prof, MD, MPH | Charité University Medical Center |
Responsible Party: | Charité - Universitätsmedizin Berlin ( Stefan N Willich, MD, MPH, MBA ) |
Study ID Numbers: | 008 |
Study First Received: | March 19, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866398 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
coronary heart disease chd stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |