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Economic Evaluation German Drug-Eluting Stent Registry

NCT00866398 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3973

Last updated 2011-01-17

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • IKKF GmbH

    collaborator UNKNOWN

  • IHF Ludwigshafen

    collaborator UNKNOWN

  • Cordis Medizinische Apparate GmbH

    collaborator OTHER

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Stefan N Willich, Prof, MD, MPH · Charité University Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2008-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866398 on ClinicalTrials.gov