Condition category
Circulatory System
Date applied
31/01/2007
Date assigned
06/03/2007
Last edited
09/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

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.