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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 : Completed
First Posted : April 10, 2012
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 8, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date June 24, 2020
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Major adverse cardiac events [ Time Frame: 12m ]
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • MACE [ Time Frame: 24/36m ]
    MACE after 24 and 36 months
  • Revascularization [ Time Frame: 12/24/36m ]
    The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
  • Stent Thrombosis [ Time Frame: 12/24/36m ]
    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: 12/24/36m ]
    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: 12/24/36m ]
    Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • Device: Drug eluting balloon
    PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
  • Device: Drug eluting stent
    PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA
Study Arms  ICMJE
  • Experimental: Drug eluting balloon
    paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
    Intervention: Device: Drug eluting balloon
  • 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
    Intervention: Device: Drug eluting stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
758
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
649
Actual Study Completion Date  ICMJE January 15, 2020
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574534
Other Study ID Numbers  ICMJE BASKET-SMALL2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators  ICMJE
Principal Investigator: Raban V Jeger, PD Dr Cardiology, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP