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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01574534
Recruitment Status : Recruiting
First Posted : April 10, 2012
Last Update Posted : January 26, 2018
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Drug eluting balloon Device: Drug eluting stent Not Applicable

Detailed Description:

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)
Estimated 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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. MACE [ Time Frame: 24/36 month ]
    MACE after 24 and 36 months

  2. Revascularization [ Time Frame: 12/24/36 month ]
    The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months

  3. 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

  4. 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

  5. Cost-effectiveness [ Time Frame: 12/24/36 month ]
    Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months

Information from the National Library of Medicine

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01574534

Contact: Raban V Jeger, PD Dr +41612655214

Medizinische Universität Graz Kardiologie Recruiting
Graz, Austria, 8036
Contact: Robert Zweiker, Prof Dr         
Cardiology, Zentralklinik Bad Berka Recruiting
Bad Berka, Germany, 99437
Contact: Marc-Alexander Ohlow, PD Dr         
Unfallkrankenhaus Berlin, Dept. Internal Medicine Recruiting
Berlin, Germany, 12683
Contact: Leonhard Bruch, MD         
Charité Universitätsmedizin Berlin, Kardiologie Recruiting
Berlin, Germany, 13353
Contact: Florian Krackhardt, MD         
Immanuel Klinikum Bernau Herzzentrum Brandenburg Recruiting
Bernau, Germany, 16321
Klinikum Westfalen GmbH Knappschaftskrankenhaus Recruiting
Dortmund, Germany, 44309
Contact: Ahmed Farah, MD         
Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin Recruiting
Homburg/Saar, Germany
Contact: Bruno Scheller, Prof Dr         
University Hospital Jena Recruiting
Jena, Germany, 07747
Contact: Sven Möbius-Winkler, PD Dr med         
Herzzentrum Leipzig GmbH, Universitätsklinik Recruiting
Leipzig, Germany, 04289
Contact: Norman Mangner, MD         
Department of Internal Medicine/Cardiology, University Hospital Ulm Recruiting
Ulm, Germany
Contact: Jochen Wöhrle, Prof. Dr. med         
Cardiology, University Hospital Basel Recruiting
Basel, Switzerland
Contact: Raban V Jeger, Prof Dr         
Cardiology Cantonal Hospital Baselland Liestal Recruiting
Liestal, Switzerland, 4410
Contact: Gregor Leibundgut, MD    061 925 23 65   
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Florim Cuculi, PD Dr         
Cardiology, Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland
Contact: Daniel Weilenmann, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Principal Investigator: Raban V Jeger, PD Dr Cardiology, University Hospital Basel

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01574534     History of Changes
Other Study ID Numbers: BASKET-SMALL2
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action