Economic Evaluation German Drug-Eluting Stent Registry

Coronary Heart Disease Clinical Trial

Official title:

Economic Evaluation German Drug-Eluting Stent Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866398
• Other study ID #: 008
• Status: Completed
• Phase: N/A
• First received: March 19, 2009
• Last updated: January 14, 2011
• Start date: December 2005
• Est. completion date: March 2008

Study information

• Verified date: January 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3973
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Boston Scientific Corporation, Cordis Medizinische Apparate GmbH, IHF Ludwigshafen, IKKF GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost equivalence of drug-eluting coronary stents versus bare metal stents		12 months	No
Secondary	MACCE		12 months	No
Secondary	Quality of life		12 months