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Completed

NCT Number: NCT00866398

Economic Evaluation German Drug-Eluting Stent Registry

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for coronary stent implantation
  • Additional inclusion criteria BMS cohort:
  • Acute Coronary Syndrome
  • Diabetes Mellitus
  • Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
  • 3-Vessel Disease

Treatment and study plan

Primary outcomes

  1. Cost equivalence of drug-eluting coronary stents versus bare metal stents

    Time frame: 12 months

Secondary outcomes

  1. MACCE

    Time frame: 12 months

  2. Quality of life

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Boston Scientific Corporation
  • Cordis Medizinische Apparate GmbH
  • IHF Ludwigshafen
  • IKKF GmbH

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Mar 20, 2009
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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