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
Scientific
Cardiology Department
University Hospital
Petersgraben 4
Basel
CH-4031
Switzerland
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | BASKET (BAsel Stent KostenEffektivitaets Trial) |
| Study objectives | Drug 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) studied | Coronary artery disease |
| Intervention | PCI in a real world setting (chronic and acute disease). Patients randomised 2:1 to drug eluting versus bare metal stents. |
| Intervention type | Other |
| Primary outcome measure | Six 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 measures | 1. 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 date | 01/05/2003 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 826 |
| Key inclusion criteria | Coronary 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 criteria | 1. In-stent-restenosis 2. Target vessel diameter equal to or greater than 4 mm 3. No informed consent |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Cardiology Department
Basel
CH-4031
Switzerland
CH-4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Petersgraben 4
Basel
CH-4031
Switzerland
| Website | http://www.universitaetsspital-basel.ch/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
