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. (see Contacts and Locations)
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
  Purpose

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 Intervention
Stenotic Coronary Arteries
Device: Drug eluting balloon
Device: Drug eluting stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 649
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug eluting balloon
paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
Device: Drug eluting balloon
PCI using paclitaxeleluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
Active Comparator: Drug eluting stent
paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA
Device: Drug eluting stent
PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574534

Contacts
Contact: Raban V Jeger, MD +41 61 265 52 14 rjeger@uhbs.ch

Locations
Germany
Zentralklinik Bad Berka Recruiting
Bad Berka, Germany, 99437
Contact: Ahmed Farah, MD         
Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin Recruiting
Homburg/Saar, Germany
Contact: Bruno Scheller, MD         
Herzzentrum Leipzig GmbH, Universitätsklinik Not yet recruiting
Leipzig, Germany, 04289
Contact: Norman Mangner, MD         
Universitätsmedizin Rostock, Abteilung für Kardiologie Recruiting
Rostock, Germany, 18057
Department of Internal Medicine/Cardiology, University Hospital Ulm Recruiting
Ulm, Germany
Contact: Jochen Wöhrle, Prof. Dr. med         
Switzerland
Cardiology, University Hospital Basel Recruiting
Basel, Switzerland
Contact: Raban V Jeger, MD         
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Paul Erne, MD         
Cardiology, Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland
Contact: Daniel Weilenmann, MD         
Sponsors and Collaborators
Raban Jeger
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
Principal Investigator: Raban V Jeger, MD Cardiology, University Hospital Basel
  More Information

No publications provided

Responsible Party: Raban Jeger, Principal Investigator, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01574534     History of Changes
Other Study ID Numbers: BASKET-SMALL2
Study First Received: April 8, 2012
Last Updated: June 18, 2013
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on September 14, 2014