Coronary Artery DiseasePhase 4GERSHWINNCT00627900
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents
A Phase 4 study testing bare metal stent and Cypher-Stent (Implantation of a sirolimus-eluting stent) in people with Coronary Artery Disease, run by Charite University, Berlin, Germany at 1 site in 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?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- bare metal stent and Cypher-Stent (Implantation of a sirolimus-eluting stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 958 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2003to Sep 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for implantation of a coronary stent
- de novo lesions < or = 30 mm in patients with diabetes
- de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes
Who cannot join
- acute MI
- lesion length >30 mm
- in-stent restenosis
- distal lesion in RVD < 2.25 mm
- lesion in left main or bypass vessel
- contraindication to Clopidogrel
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Berlin, 10098
About this study
Official title: Model Project for the Reduction of Coronary Restenosis
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 "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) 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, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.
Read more
In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.
In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years
- Conditions
- Coronary Artery Disease
- Being tested
- bare metal stent, Cypher-Stent (Implantation of a sirolimus-eluting stent)
- Keywords
- drug-eluting stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bare metal stentDevice
implantation of a bare metal stent
Cypher-Stent (Implantation of a sirolimus-eluting stent)Device
Also called Cypher-Stent
Implantation of a sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| BMS | Other | Implantation of a bare metal stent Receives: Device: bare metal stent |
| SES | Other | Implantation of a sirolimus-eluting stent Receives: Device: Cypher-Stent (Implantation of a sirolimus-eluting stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents
Measured: 3,6,12,18,24, 36 months following stent implantation
Secondary outcomes (1)
MACE (re-PCI, myocardial infarction, CABG, death)
Measured: 3,6,12,24,36 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startApr 2003
- Primary completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Techniker Krankenkasse
- Investigators
- Stefan N Willich, MD, MPH, MBA, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627900
- Sponsor's protocol ID
- EK-Vorgang: Verschiedenes
- Acronym
- GERSHWIN
- Status last verified
- Feb 2008
- First submitted
- 24 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruggenjurgen B, McBride D, Bode C, Hamm CW, Kuck KH, Willich SN. Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study. Herz. 2007 Dec;32(8):650-5. doi: 10.1007/s00059-007-3048-2.
PubMed 18060612
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Project for the Reduction of Coronary Restenosis
- ClinicalTrials.gov ID
- NCT00627900
- Acronym / sponsor ID
- GERSHWIN / EK-Vorgang: Verschiedenes
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Techniker Krankenkasse
- Study start
- Apr 2003
- Primary completion
- Sep 2008 (estimated)
- First posted
- 4 Mar 2008 (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 "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) 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, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.
In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.
In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years
Study design
- Allocation
- Non-randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS | Other | Device: bare metal stentImplantation of a bare metal stent |
| SES | Other | Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)Implantation of a sirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for implantation of a coronary stent
- de novo lesions < or = 30 mm in patients with diabetes
- de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes
Key exclusion criteria (6 listed)
- acute MI
- lesion length >30 mm
- in-stent restenosis
- distal lesion in RVD < 2.25 mm
- lesion in left main or bypass vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bare metal stentimplantation of a bare metal stent | Device | BMS |
| Cypher-Stent (Implantation of a sirolimus-eluting stent)Also: Cypher-StentImplantation of a sirolimus-eluting stent | Device | SES |
Primary outcome
Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents
Time frame: 3,6,12,18,24, 36 months following stent implantation
1 secondary outcome
MACE (re-PCI, myocardial infarction, CABG, death)
Time frame: 3,6,12,24,36 months after stent implantation
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 4 Mar 2008.
- Results publication: PubMed 18060612Bruggenjurgen B, McBride D, Bode C, Hamm CW, Kuck KH, Willich SN. Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study. Herz. 2007 Dec;32(8):650-5. doi: 10.1007/s00059-007-3048-2.
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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, MD, MPH, MBA study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bare metal stent and Cypher-Stent (Implantation of a sirolimus-eluting stent) in people with Coronary Artery Disease, run by Charite University, Berlin, Germany at 1 site in 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 3 inclusion and 6 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sirolimus-eluting coronary stents versus bare metal stents (time frame: 3,6,12,18,24, 36 months following stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627900, which also lists 1 linked publication.
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 4 Mar 2008.