Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01574534 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : June 24, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Device: Drug eluting balloon Device: Drug eluting stent | Not Applicable |
Drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. Moreover, the available data suggest that DEB are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided.
The aim of this study is to demonstrate that DEB is non-inferior to DES in a real-world population with respect to the combined clinical endpoint Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 758 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | February 1, 2018 |
Actual Study Completion Date : | January 15, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Drug eluting balloon
paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
|
Device: Drug eluting balloon
PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany |
Active Comparator: Drug eluting stent
paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA
|
Device: Drug eluting stent
PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA |
- Major adverse cardiac events [ Time Frame: 12 month ]Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
- MACE [ Time Frame: 24/36 month ]MACE after 24 and 36 months
- Revascularization [ Time Frame: 12/24/36 month ]The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
- Stent Thrombosis [ Time Frame: 12/24/36 month ]Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, and 36 months; all stent thromboses defined according to the ARC criteria after 12, 24, and 36 months
- Thrombolysis In Myocardial Infarction [ Time Frame: 12/24/36 month ]
Thrombolysis In Myocardial Infarction (TIMI) major bleeding after 12, 24, and 36 months
Net clinical benefit consisting of the primary endpoint and the TIMI major bleeding after 12, 24, and 36 months
- Cost-effectiveness [ Time Frame: 12/24/36 month ]Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
- Quantitative Coronary Analysis (QCA) [ Time Frame: 12 months ]QCA of patients who had events which required CAG/PCI after Baseline PCI
- Outcome in patients with high bleeding risk including patients on OAC [ Time Frame: 12 months ]Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)
- Outcome in acute versus stable CAD [ Time Frame: 12 months ]Difference of the Population with acute versus stable CAD with regard to baseline characteristics, primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
- Outcome in diabetics vs non diabetics [ Time Frame: 12 months ]Difference of the diabetic versus non-diabetic population regarding baseline characteristics and primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
- sex specific inequalities in the use of drug coated balloons for small coronary artery disease [ Time Frame: 12 months ]sex specific difference in baseline charchteristics, Impact of sex on safety and efficacy in the stent-free strategy regarding primary and secondary endpoint (MACE, stent thrombosis, major bleeding)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve
- PCI of de-novo stenosis in vessels ≥2.0 to <3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel)
- No flow-limiting dissection (TIMI ≤2) or residual stenosis >30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge
- Written informed consent
Exclusion Criteria:
- Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA)
- PCI of instent-restenosis (culprit lesion)
- Life expectancy <12 months
- Pregnancy
- Enrolled in another coronary intervention study
- Unable to give informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574534
Austria | |
Medizinische Universität Graz Kardiologie | |
Graz, Austria, 8036 | |
Germany | |
Cardiology, Zentralklinik Bad Berka | |
Bad Berka, Germany, 99437 | |
Unfallkrankenhaus Berlin, Dept. Internal Medicine | |
Berlin, Germany, 12683 | |
Charité Universitätsmedizin Berlin, Kardiologie | |
Berlin, Germany, 13353 | |
Immanuel Klinikum Bernau Herzzentrum Brandenburg | |
Bernau, Germany, 16321 | |
Klinikum Westfalen GmbH Knappschaftskrankenhaus | |
Dortmund, Germany, 44309 | |
Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin | |
Homburg/Saar, Germany | |
University Hospital Jena | |
Jena, Germany, 07747 | |
Herzzentrum Leipzig GmbH, Universitätsklinik | |
Leipzig, Germany, 04289 | |
Department of Internal Medicine/Cardiology, University Hospital Ulm | |
Ulm, Germany | |
Switzerland | |
Cardiology, University Hospital Basel | |
Basel, Switzerland | |
Cardiology Cantonal Hospital Baselland Liestal | |
Liestal, Switzerland, 4410 | |
Luzerner Kantonsspital | |
Luzern, Switzerland, 6000 | |
Cardiology, Kantonsspital St. Gallen | |
St. Gallen, Switzerland |
Principal Investigator: | Raban V Jeger, PD Dr | Cardiology, University Hospital Basel |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT01574534 |
Other Study ID Numbers: |
BASKET-SMALL2 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | June 24, 2020 |
Last Verified: | June 2020 |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |