Late clinical events after paclitaxel- vs. zotarolimus-eluting stents in patients with small vessel stenting
| ISRCTN | ISRCTN09125734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09125734 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2007
- Registration date
- 06/03/2007
- Last edited
- 09/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Raban Jeger
Scientific
Scientific
Department of Cardiology
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 61 265 52 14 |
|---|---|
| raban.jeger@usb.ch |
Study information
| Study design | Prospective randomized open-label single-center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | BAsel Stent Kosten Effektivitäts Trial - late clinical events in patients with SMALL vessel stenting |
| Study acronym | BASKET-SMALL |
| Study objectives | Hypothesis as of 09/05/2016: The question, whether late outcome may be improved further by a new generation of drug-eluting stent (DES), the zotarolimus-eluting Endeavor® stent compared to a first generation DES, the Taxus® stent, is not known and will be addressed in the prospective randomized BASKET-SMALL pilot study. Specific aims of BASKET-SMALL pilot will, therefore, be: 1. To compare two drug-eluting stents, the first generation Taxus® stent with the second generation Endeavor® stent in patients with at least one stent <3.0 mm on clinical outcome after 24 months. 2. To compare these data to the findings of similar patients in BASKET-LATE (historical control) treated with the BMS Vision®. Original hypothesis: The question, whether late outcome may be improved further by a new generation of drug-eluting stent (DES) with a totally absorbable polymer such as the Co-Star® stent (Conor Med System, Menlow Park, CA, USA) which is CE marketed and in use in Basel since 2006 compared to a first generation DES with the same drug coating, the Taxus® stent, is not known and will be addressed in the prospective randomized BASKET-SMALL pilot study. Specific aims of BASKET-SMALL pilot will, therefore, be: 1. To compare two paclitaxel-eluting stents, the first generation Taxus® stent with the second generation Co-Star® stent with a totally absorbable polymer in patients with at least one stent <3.0 mm on clinical outcome after 18 months. 2. To compare these data to the findings of similar patients in BASKET-LATE (historical control) treated with the BMS Vision®. |
| Ethics approval(s) | Ethikkommission beider Basel, 11/12/2006, ref: 326/06 |
| Health condition(s) or problem(s) studied | Coronary artery diesease |
| Intervention | Interventions as of 09/05/2016: Randomization will be 1:1 to Taxus® (standard 1st generation DES with paclitaxel) versus Endeavor® (2nd generation DES with zotarolimus). Origianl interventions: Randomization will be 1:1 to: Taxus® (standard 1st generation DES) versus Co-Star® (DES with biodegradable polymer) |
| Intervention type | Other |
| Primary outcome measure | Primary outcome measures as of 09/05/2016: Absence of both major adverse cardiac events (MACE), i.e., of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) 3. Non-MI-related target vessel revascularization (TVR) All after 18 months Original primary outcome measures: Absence of both of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) after 18 months |
| Secondary outcome measures | Secondary outcome measures as of 09/05/2016: 1. Primary end-point events up to 12 and 24 months 2. Non-cardiac death (total death) 3. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) 4. Net clinical benefit = primary end-point + bleeding Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents < 3mm Original secondary outcome measures: 1. Non-MI related target vessel revascularization (TVR) 2. Major adverse cardiac events (MACE) = primary end-point events + non-MI related TVR 3. Primary end-point events up to 12 and 24 months 4. Non-cardiac death (total death) 5. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) net clinical benefit = primary end-point + bleeding. 6. Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents < 3mm |
| Overall study start date | 01/03/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 1. All comers, 24 hours a day, 7 days a week, irrespective of indication for percutaneous coronary intervention (PCI) 2. With the need of small vessel stenting (at least one stent <3.0 mm) |
| Key exclusion criteria | 1. In-stent-restenosis 2. Bypass graft disease 3. Main stem disease to be stented 4. Cardiogenic shock 5. Planned surgery within the next 6 months 6. Oral anticoagulation needed (artificial heart valves, atrial fibrillation) 7 No compliance expected 8. Enrolled in another study 9. No consent |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Department of Cardiology
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel
University/education
University/education
Department of Cardiology
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 61 265 52 14 |
|---|---|
| raban.jeger@usb.ch | |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Charity
Foundation for Cardiovascular Research (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 |
Editorial Notes
09/05/2016: A public title has been added and the study contact has been updated from Prof Matthias Pfisterer to Prof Raban Jeger. In addition, the hypothesis, interventions and outcome measures fields have been updated.
