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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01574534
First received: April 8, 2012
Last updated: January 23, 2017
Last verified: January 2017
  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
Coronary Heart Disease Device: Drug eluting balloon Device: Drug eluting stent

Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 758
Study Start Date: April 2012
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (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 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

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   (Adult, Senior)
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
  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, PD Dr +41612655214 raban.jeger@usb.ch

Locations
Austria
Medizinische Universität Graz Kardiologie Recruiting
Graz, Austria, 8036
Contact: Robert Zweiker, Prof Dr         
Germany
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         
Switzerland
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    Gregor.Leibundgut@ksbl.ch   
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
Investigators
Principal Investigator: Raban V Jeger, PD Dr Cardiology, University Hospital Basel
  More Information

Responsible Party: 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: January 23, 2017

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 17, 2017