Economic Evaluation German Drug-Eluting Stent Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3973 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 DES

Patients receiving drug-eluting stent

No interventions assigned to this group

2 BMS

Patients receiving bare metal stent

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Indication for coronary stent implantation

* Acute Coronary Syndrome
* Diabetes Mellitus
* Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
* 3-Vessel Disease

Eligible Sex

ALL

Accepts Healthy Volunteers

No