Coronary Heart DiseaseNCT00866398
Economic Evaluation German Drug-Eluting Stent Registry
An observational study of Coronary Heart Disease, run by Charite University, Berlin, Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 3,973 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary heart disease, eligible for stent implantation.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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.
- Conditions
- Coronary Heart Disease
- Keywords
- coronary heart disease, chd, stent
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 DES | Patients receiving drug-eluting stent | |
| 2 BMS | Patients receiving bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost equivalence of drug-eluting coronary stents versus bare metal stents
Measured: 12 months
Secondary outcomes (2)
MACCE
Measured: 12 months
Quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- IKKF GmbH, IHF Ludwigshafen, Cordis Medizinische Apparate GmbH, Boston Scientific Corporation
- Investigators
- Stefan N Willich, Prof, MD, MPH, Study director, Charité University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866398
- Sponsor's protocol ID
- 008
- Status last verified
- Jan 2011
- First submitted
- 19 Mar 2009
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation German Drug-Eluting Stent Registry
- ClinicalTrials.gov ID
- NCT00866398
- Acronym / sponsor ID
- 008
- Conditions
- Coronary Heart Disease
- Keywords
- coronary heart disease, chd, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,973 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- IKKF GmbH, IHF Ludwigshafen, Cordis Medizinische Apparate GmbH, Boston Scientific Corporation
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 DES | – | –Patients receiving drug-eluting stent |
| 2 BMS | – | –Patients receiving bare metal stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary heart disease, eligible for stent implantation.
Key inclusion criteria (6 listed)
- Indication for coronary stent implantation
- Additional inclusion criteria BMS cohort:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost equivalence of drug-eluting coronary stents versus bare metal stents
Time frame: 12 months
2 secondary outcomes
MACCE
Time frame: 12 months
Quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan N Willich, Prof, MD, MPH study director
Charité University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost equivalence of drug-eluting coronary stents versus bare metal stents (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.