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Coronary Heart DiseaseBASKET-SMALL2NCT01574534

Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

A study testing Drug eluting balloon and Drug eluting stent in people with Coronary Heart Disease, run by University Hospital, Basel, Switzerland at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Drug eluting balloon and Drug eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
758 participants
Where
14 sitesin 3 countries
Study dates
Apr 2012to 15 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Germany9 sites

  • Cardiology, Zentralklinik Bad Berka

    Bad Berka, 99437

  • Unfallkrankenhaus Berlin, Dept. Internal Medicine

    Berlin, 12683

  • Charité Universitätsmedizin Berlin, Kardiologie

    Berlin, 13353

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau, 16321

  • Klinikum Westfalen GmbH Knappschaftskrankenhaus

    Dortmund, 44309

  • Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin

    Homburg/Saar

  • University Hospital Jena

    Jena, 07747

  • Herzzentrum Leipzig GmbH, Universitätsklinik

    Leipzig, 04289

  • Department of Internal Medicine/Cardiology, University Hospital Ulm

    Ulm

Other trials in Germany

Switzerland4 sites

  • Cardiology, University Hospital Basel

    Basel

  • Cardiology Cantonal Hospital Baselland Liestal

    Liestal, 4410

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Cardiology, Kantonsspital St. Gallen

    Sankt Gallen

Other trials in Switzerland

Austria1 site

  • Medizinische Universität Graz Kardiologie

    Graz, 8036

Other trials in Austria

About this study

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

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).

Read the 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.

Being tested
Drug eluting balloon, Drug eluting stent
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug eluting balloonDevice

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

  • Drug eluting stentDevice

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

Study groups in NCT01574534
Study groupRoleWhat they receive
Drug eluting balloonExperimentalpaclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
Receives: Device: Drug eluting balloon
Drug eluting stentActive comparatorpaclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA
Receives: Device: Drug eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 month

Secondary outcomes (10)

  1. MACE

    MACE after 24 and 36 months

    Measured: 24/36 month

  2. Revascularization

    The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months

    Measured: 12/24/36 month

  3. Stent Thrombosis

    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

    Measured: 12/24/36 month

  4. Thrombolysis In Myocardial Infarction

    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

    Measured: 12/24/36 month

  5. Cost-effectiveness

    Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months

    Measured: 12/24/36 month

  6. Quantitative Coronary Analysis (QCA)

    QCA of patients who had events which required CAG/PCI after Baseline PCI

    Measured: 12 months

  7. Outcome in patients with high bleeding risk including patients on OAC

    Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)

    Measured: 12 months

  8. Outcome in acute versus stable CAD

    Difference of the Population with acute versus stable CAD with regard to baseline characteristics, primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)

    Measured: 12 months

  9. Outcome in diabetics vs non diabetics

    Difference of the diabetic versus non-diabetic population regarding baseline characteristics and primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)

    Measured: 12 months

  10. sex specific inequalities in the use of drug coated balloons for small coronary artery disease

    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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completion1 Feb 2018
  4. Study completion15 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01574534
Sponsor's protocol ID
BASKET-SMALL2
Acronym
BASKET-SMALL2
Status last verified
Jun 2020
First submitted
8 Apr 2012
Last updated
24 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29527709

  • 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.

    PubMed 30170854

  • 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.

    PubMed 37495797

  • 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.

    PubMed 35411792

  • 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.

    PubMed 35000455

  • 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.

    PubMed 34412797

  • 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.

    PubMed 33091360

  • 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.

    PubMed 31993736

Questions about this trial

What is this clinical trial studying?

A study testing Drug eluting balloon and Drug eluting stent in people with Coronary Heart Disease, run by University Hospital, Basel, Switzerland at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac events (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01574534, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.

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