Contact information
Type
Scientific
Primary contact
Prof Raban Jeger
ORCID ID
Contact details
Department of Cardiology
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
+41 61 265 52 14
raban.jeger@usb.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
BAsel Stent Kosten Effektivitäts Trial - late clinical events in patients with SMALL vessel stenting
Acronym
BASKET-SMALL
Study hypothesis
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
Ethikkommission beider Basel, 11/12/2006, ref: 326/06
Study design
Prospective randomized open-label single-center trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/03/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
Department of Cardiology
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel
Sponsor details
Department of Cardiology
Petersgraben 4
Basel
4031
Switzerland
+41 61 265 52 14
raban.jeger@usb.ch
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Foundation for Cardiovascular Research (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary