NCT00866398

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,973

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

Enrollment Period

1.8 years

First QC Date

March 19, 2009

Last Update Submit

January 14, 2011

Conditions

Coronary Heart Disease

Keywords

coronary heart diseasechdstent

Outcome Measures

Primary Outcomes (1)

  • Cost equivalence of drug-eluting coronary stents versus bare metal stents

    12 months

Secondary Outcomes (2)

  • MACCE

    12 months

  • Quality of life

    12 months

Study Arms (2)

1 DES

Patients receiving drug-eluting stent

2 BMS

Patients receiving bare metal stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary heart disease, eligible for stent implantation.

You may qualify if:

  • Indication for coronary stent implantation
  • Acute Coronary Syndrome
  • Diabetes Mellitus
  • Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
  • Vessel Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stefan N Willich, Prof, MD, MPH

    Charité University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

December 1, 2005

Primary Completion

October 1, 2007

Study Completion

March 1, 2008

Last Updated

January 17, 2011

Record last verified: 2011-01