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Economic Evaluation German Drug-Eluting Stent Registry

Economic Evaluation German Drug-Eluting Stent Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00866398
Enrollment
3973
Registered
2009-03-20
Start date
2005-12-31
Completion date
2008-03-31
Last updated
2011-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

coronary heart disease, chd, stent

Brief 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.

Interventions

None listed

Sponsors

IKKF GmbH
CollaboratorUNKNOWN
IHF Ludwigshafen
CollaboratorUNKNOWN
Cordis Medizinische Apparate GmbH
CollaboratorOTHER
Boston Scientific Corporation
CollaboratorINDUSTRY
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cost equivalence of drug-eluting coronary stents versus bare metal stents12 months

Secondary

MeasureTime frame
MACCE12 months
Quality of life12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026