Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2)

This study is currently recruiting participants.
Verified June 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Raban Jeger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01574534
First received: April 8, 2012
Last updated: June 18, 2013
Last verified: June 2013

April 8, 2012
June 18, 2013
April 2012
March 2014   (final data collection date for primary outcome measure)
Major adverse cardiac events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Major adverse cardiac events [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Complete list of historical versions of study NCT01574534 on ClinicalTrials.gov Archive Site
  • MACE [ Time Frame: 24/36 month ] [ Designated as safety issue: Yes ]
    MACE after 24 and 36 months
  • Revascularization [ Time Frame: 12/24/36 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
  • MACE [ Time Frame: 24/36m ] [ Designated as safety issue: Yes ]
    MACE after 24 and 36 months
  • Revascularization [ Time Frame: 12/24/36m ] [ Designated as safety issue: Yes ]
    The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
  • Stent Thrombosis [ Time Frame: 12/24/36m ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
Not Provided
Not Provided
 
Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stenotic Coronary Arteries
  • Device: Drug eluting balloon
    PCI using paclitaxeleluting 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
  • 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
    Intervention: Device: Drug eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
649
March 2016
March 2014   (final data collection date for primary outcome measure)

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, RCX, RCA)
  • PCI of instent-restenosis (culprit lesion)
  • Oral anticoagulation
  • Planned surgery within the following 12 months
  • History of intracranial bleeding
  • Life expectancy <12 months
  • Pregnancy
  • Enrolled in another coronary intervention study
  • Unable to give informed consent
Both
18 Years and older
No
Contact: Raban V Jeger, MD +41 61 265 52 14 rjeger@uhbs.ch
Germany,   Switzerland
 
NCT01574534
BASKET-SMALL2
No
Raban Jeger, University Hospital, Basel, Switzerland
Raban Jeger
Clinical Trial Unit, University Hospital Basel, Switzerland
Principal Investigator: Raban V Jeger, MD Cardiology, University Hospital Basel
University Hospital, Basel, Switzerland
June 2013

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