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Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL2)

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ClinicalTrials.gov Identifier: NCT01574534
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
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.


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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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 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




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

  6. Quantitative Coronary Analysis (QCA) [ Time Frame: 12 months ]
    QCA of patients who had events which required CAG/PCI after Baseline PCI

  7. 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)

  8. 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)

  9. 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)

  10. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01574534


Locations
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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
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Raban V Jeger, PD Dr Cardiology, University Hospital Basel

Publications of Results:
Other Publications:
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01574534     History of Changes
Other Study ID Numbers: BASKET-SMALL2
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action