BAsel Stent KostenEffektivitaets Trial (Basel Stent cost-effectiveness trial)

ISRCTN ISRCTN75663024
DOI https://doi.org/10.1186/ISRCTN75663024
Secondary identifying numbers N/A
Submission date
26/10/2006
Registration date
03/11/2006
Last edited
15/11/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Matthias Pfisterer
Scientific

Cardiology Department
University Hospital
Petersgraben 4
Basel
CH-4031
Switzerland

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymBASKET (BAsel Stent KostenEffektivitaets Trial)
Study objectivesDrug Eluting Stents (DES) are not cost-effective in a real world setting when compared to bare metal stents.
Ethics approval(s)Approved by the local ethics committee of the University of Basel, March 27, 2003.
Health condition(s) or problem(s) studiedCoronary artery disease
InterventionPCI in a real world setting (chronic and acute disease). Patients randomised 2:1 to drug eluting versus bare metal stents.
Intervention typeOther
Primary outcome measureSix month cost-effectiveness with effectiveness defined as reduction of major adverse cardiac events - i.e., cardiac death, non-fatal myocardial infarction and target vessel revascularisation.
Secondary outcome measures1. Mortality from other cause, target vessel ischemia by myocardial perfusion Single Photon Emission Computed Tomography (SPECT).
2. Effectiveness of DES in patients with myocardial infarction and saphenous vein graft disease.
3. Cost-effectiveness as defined above after 18 and 36 months.
Overall study start date01/05/2003
Completion date31/05/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants826
Key inclusion criteriaCoronary artery disease suitable for interventional therapy.

All patients referred for cardiac catheterisation and subsequent Percutaneous Coronary Intervention (PCI) irrespective of clinical indication, who are able to provide written informed consent.
Key exclusion criteria1. In-stent-restenosis
2. Target vessel diameter equal to or greater than 4 mm
3. No informed consent
Date of first enrolment01/05/2003
Date of final enrolment31/05/2004

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Cardiology Department
Basel
CH-4031
Switzerland

Sponsor information

University Hospital Basel (Switzerland)
Hospital/treatment centre

Petersgraben 4
Basel
CH-4031
Switzerland

Website http://www.universitaetsspital-basel.ch/
ROR logo "ROR" https://ror.org/04k51q396

Funders

Funder type

Hospital/treatment centre

University Hospital, Basel (Switzerland)

No information available

Cardiac Research Foundation, Basel (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/09/2005 Yes No
Other publications -month cost-effectiveness analysis: 03/11/2007 Yes No