NCT01574534

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
758

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

5.8 years

First QC Date

April 8, 2012

Last Update Submit

June 23, 2020

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

    12 month

Secondary Outcomes (10)

  • MACE

    24/36 month

  • Revascularization

    12/24/36 month

  • Stent Thrombosis

    12/24/36 month

  • Thrombolysis In Myocardial Infarction

    12/24/36 month

  • Cost-effectiveness

    12/24/36 month

  • +5 more secondary outcomes

Study Arms (2)

Drug eluting balloon

EXPERIMENTAL

paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany

Device: Drug eluting balloon

Drug eluting stent

ACTIVE COMPARATOR

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

Interventions

Drug eluting balloonDEVICE

PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany

Drug eluting balloon
Drug eluting stentDEVICE

PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

Drug eluting stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Medizinische Universität Graz Kardiologie

Graz, 8036, Austria

Location

Cardiology, Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Unfallkrankenhaus Berlin, Dept. Internal Medicine

Berlin, 12683, Germany

Location

Charité Universitätsmedizin Berlin, Kardiologie

Berlin, 13353, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Klinikum Westfalen GmbH Knappschaftskrankenhaus

Dortmund, 44309, Germany

Location

Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin

Homburg/Saar, Germany

Location

University Hospital Jena

Jena, 07747, Germany

Location

Herzzentrum Leipzig GmbH, Universitätsklinik

Leipzig, 04289, Germany

Location

Department of Internal Medicine/Cardiology, University Hospital Ulm

Ulm, Germany

Location

Cardiology, University Hospital Basel

Basel, Switzerland

Location

Cardiology Cantonal Hospital Baselland Liestal

Liestal, 4410, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Cardiology, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

Related Publications (8)

  • Gilgen N, Farah A, Scheller B, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Jamshidi P, Leibundgut G, Mobius-Winkler S, Zweiker R, Krackhardt F, Butter C, Bruch L, Kaiser C, Hoffmann A, Rickenbacher P, Mueller C, Stephan FP, Coslovsky M, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2. Clin Cardiol. 2018 May;41(5):569-575. doi: 10.1002/clc.22942. Epub 2018 May 10.

    PMID: 29527709BACKGROUND

  • Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.

    PMID: 30170854RESULT

  • Rubini Gimenez M, Scheller B, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Cattaneo M, Gilgen N, Kaiser C, Jeger RV. Sex-specific inequalities in the use of drug-coated balloons for small coronary artery disease: a report from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2024 Jul;113(7):959-966. doi: 10.1007/s00392-023-02249-6. Epub 2023 Jul 26.

    PMID: 37495797DERIVED

  • Scheller B, Rissanen TT, Farah A, Ohlow MA, Mangner N, Wohrle J, Mobius-Winkler S, Weilenmann D, Leibundgut G, Cuculi F, Gilgen N, Coslovsky M, Mahfoud F, Jeger RV; BASKET-SMALL 2 Investigators. Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial. Circ Cardiovasc Interv. 2022 Apr;15(4):e011569. doi: 10.1161/CIRCINTERVENTIONS.121.011569. Epub 2022 Apr 12.

    PMID: 35411792DERIVED

  • Mangner N, Farah A, Ohlow MA, Mobius-Winkler S, Weilenmann D, Wohrle J, Linke A, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Scheller B, Jeger RV; BASKET-SMALL 2 Investigators. Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2. Circ Cardiovasc Interv. 2022 Feb;15(2):e011325. doi: 10.1161/CIRCINTERVENTIONS.121.011325. Epub 2022 Jan 10.

    PMID: 35000455DERIVED

  • Wohrle J, Scheller B, Seeger J, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Stachel G, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Jeger RV; BASKET-SMALL 2 Investigators. Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1789-1798. doi: 10.1016/j.jcin.2021.06.025.

    PMID: 34412797DERIVED

  • Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.

    PMID: 33091360DERIVED

  • Fahrni G, Scheller B, Coslovsky M, Gilgen N, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Zweiker R, Twerenbold R, Kaiser C, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2020 Sep;109(9):1114-1124. doi: 10.1007/s00392-020-01603-2. Epub 2020 Jan 29.

    PMID: 31993736DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Raban V Jeger, PD Dr

    Cardiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2012

First Posted

April 10, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2018

Study Completion

January 15, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

AU(1)DE(9)CH(4)