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ST Elevation Myocardial Infarction (STEMI)BOOST-AMINCT06746233

Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

A study testing Drug (paclitaxel) coated balloon (DCB) and Second-generation Drug Eluting Stent (DES) in people with ST Elevation Myocardial Infarction (STEMI), run by Institute of Cardiovascular Diseases, Vojvodina at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug (paclitaxel) coated balloon (DCB) and Second-generation Drug Eluting Stent (DES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
598 participants
Where
5 sitesin 2 countries
Study dates
25 Dec 2024to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age >18 years with a life expectancy of >1 year;
  • Patients fulfilling criteria for STEMI (>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
  • Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Who cannot join

  • Killip class>II on admission
  • Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
  • Previous myocardial infarction
  • Previous PCI in the territory of the infarct-related artery (IRA)
  • Previous CABG
  • 3-vessel disease requiring revascularization
Show all 11Show fewer
  • Left-main disease
  • Extremely angulated or severely calcified vessels
  • History of ischemic stroke within the past 6 months or hemorrhagic stroke
  • Planned CABG for a non-culprit vessel
  • Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Mila Kovačević, MD, PhD contact

+381601594444

milakov979@gmail.com

Branislav Crnomarković, MD contact

+381642636495

branislavc.89@gmail.com

5 sites in 2 countries

Serbia4 sites, 4 recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000

    Zlatko Mehmedbegović, MD, +381606678761, zlatkombegovic@gmail.com

    Zlatko Mehmedbegović, MD

    Recruiting

  • Institute of Cardiovascular Diseases of Vojvodina

    Kamenitz, 21204

    Mila Kovačević, MD, PhD, +381601594444, milakov979@gmail.com

    Milovan Petrović, MD, PhD, +381641153076, petrovici@hotmail.com

    Recruiting

  • University Clinical Center of Kragujevac

    Kragujevac, 34000

    Miodrag Srećković, MD, PhD, +381693371777, sreckovic7@gmail.com

    Miodrag Srećković, MD, PhD

    Not yet recruiting

  • University Clinical Centre of Nis

    Niš, Serbia, 18105

    Bojan Maričić, MD, PhD, +381692918755, bokimaricic@gmail.com

    Bojan Maričić, MD, PhD

    Not yet recruiting

Other trials in Serbia

Bosnia and Herzegovina1 site, 1 recruiting

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 21204

    Bojan Stanetić, MD, PhD, +38765614340, bojan.stanetic@gmail.com

    Bojan Stanetić, MD, PhD

    Recruiting

Other trials in Bosnia and Herzegovina

About this study

Official title: A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.

Being tested
Drug (paclitaxel) coated balloon (DCB), Second-generation Drug Eluting Stent (DES)
Keywords
STEMI, DES, DCB
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

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

  • Drug (paclitaxel) coated balloon (DCB)Device

    In the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg/mm² will be used in STEMI patients after successful lesion preparation (defined as residual stenosis ≤30%, TIMI flow grade 2-3, and absence of flow-limiting dissection). If the result after DCB treatment is unsatisfactory, bailout implantation of a drug-eluting stent (DES) will be performed at the operator's discretion.

  • Second-generation Drug Eluting Stent (DES)Device

    In the control arm, patients randomized to the DES treatment group will undergo implantation of a second-generation drug-eluting stent (DES) using standard techniques, according to current practice guidelines

Study groups in NCT06746233
Study groupRoleWhat they receive
Drug coated balloon (DCB)ExperimentalDrug (paclitaxel) coated balloon (DCB) with concentration of 3-3.5 μg Paclitaxel per 1 mm2
Receives: Device: Drug (paclitaxel) coated balloon (DCB)
Second generation of drug eluting stents (DES)Active comparatorDrug eluting stent (DES)
Receives: Device: Second-generation Drug Eluting Stent (DES)

What is being measured

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

  1. DoCE (Device-oriented composite endpoint)

    DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).

    Measured: 1 year and 2 years

Secondary outcomes (5)

  1. Individual components of the primary endpoint (DoCE)

    Individual components of the primary endpoint (DoCE):

    • Cardiac mortality
    • Non-fatal target vessel myocardial infarction (NF-TVMI)
    • Target lesion revascularization (TLR)

    Measured: 1 year and 2 years

  2. Patient-oriented composite endpoint (PoCE)

    PoCE: Defined as a composite of all-cause death, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.

    Measured: 1 year and 2 years

  3. Target vessel revascularization (TVR)

    Measured: 1 year and 2 years

  4. Target vessel failure (TVF)

    Target Vessel Failure (TVF): Defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically or physiologically indicated target vessel revascularization (TVR).

    Measured: 1 year and 2 years

  5. BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.

    Measured: 1 year and 2 years

Timeline

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

  1. First posted24 Dec 2024
  2. Study start25 Dec 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

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
598 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746233
Sponsor's protocol ID
ICDVojvodina 1482-1/3
Acronym
BOOST-AMI
Status last verified
Mar 2026
First submitted
13 Dec 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Scheller B, Eccleshall S. Drug-coated balloons for acute coronary syndromes. EuroIntervention. 2024 Jul 1;20(13):e791-e792. doi: 10.4244/EIJ-E-24-00019. No abstract available.

    PubMed 38949238

  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.

    PubMed 37740496

  • Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, Reinhold J, Wickramarachchi U, Maart C, Gilbert T, Richardson P, Sulfi S, Sarev T, Sawh C, Wistow T, Ryding A, Mohamed MO, Perperoglou A, Mamas MA, Vassiliou VS, Eccleshall SC. Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI. JACC Cardiovasc Interv. 2023 Apr 10;16(7):771-779. doi: 10.1016/j.jcin.2023.01.380.

    PubMed 37045498

  • Fang Z, Ji J, He S, Liu N, Xu B. Drug-Coated Balloon vs. Drug-Eluting Stent in Acute Myocardial Infarction: A Systematic Review and Updated Meta-Analysis. Anatol J Cardiol. 2023 Jul 1;27(8):444-452. doi: 10.14744/AnatolJCardiol.2023.2953. Epub 2023 Jun 15.

    PubMed 37329115

  • Wang Z, Yin Y, Li J, Qi W, Yu B, Xu Z, Zhu W, Yang F, Cao M, Zhang H. New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction - A Prospective Randomized Trial. Circ J. 2022 Mar 25;86(4):642-650. doi: 10.1253/circj.CJ-21-0315. Epub 2021 Nov 10.

    PubMed 34759131

  • Hao X, Huang D, Wang Z, Zhang J, Liu H, Lu Y. Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. J Cardiothorac Surg. 2021 Jun 21;16(1):178. doi: 10.1186/s13019-021-01525-8.

    PubMed 34154628

  • Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.

    PubMed 31126887

  • Gobic D, Tomulic V, Lulic D, Zidan D, Brusich S, Jakljevic T, Zaputovic L. Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study. Am J Med Sci. 2017 Dec;354(6):553-560. doi: 10.1016/j.amjms.2017.07.005. Epub 2017 Jul 19.

    PubMed 29208251

  • 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

  • Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

    PubMed 30522667

  • Indermuehle A, Bahl R, Lansky AJ, Froehlich GM, Knapp G, Timmis A, Meier P. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart. 2013 Mar;99(5):327-33. doi: 10.1136/heartjnl-2012-302945. Epub 2013 Jan 18.

    PubMed 23335497

  • Kawai T, Watanabe T, Yamada T, Morita T, Furukawa Y, Tamaki S, Kawasaki M, Kikuchi A, Seo M, Nakamura J, Tachibana K, Kida H, Sotomi Y, Sakata Y, Fukunami M. Coronary vasomotion after treatment with drug-coated balloons or drug-eluting stents: a prospective, open-label, single-centre randomised trial. EuroIntervention. 2022 Jun 3;18(2):e140-e148. doi: 10.4244/EIJ-D-21-00636.

    PubMed 34757917

  • Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.

    PubMed 25349065

  • Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study. PLoS One. 2016 Jan 29;11(1):e0147057. doi: 10.1371/journal.pone.0147057. eCollection 2016.

    PubMed 26824602

  • Madhavan MV, Kirtane AJ, Redfors B, Genereux P, Ben-Yehuda O, Palmerini T, Benedetto U, Biondi-Zoccai G, Smits PC, von Birgelen C, Mehran R, McAndrew T, Serruys PW, Leon MB, Pocock SJ, Stone GW. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 Feb 18;75(6):590-604. doi: 10.1016/j.jacc.2019.11.058.

    PubMed 32057373

Questions about this trial

What is this clinical trial studying?

A study testing Drug (paclitaxel) coated balloon (DCB) and Second-generation Drug Eluting Stent (DES) in people with ST Elevation Myocardial Infarction (STEMI), run by Institute of Cardiovascular Diseases, Vojvodina at 5 sites in 2 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Serbia, Bosnia and Herzegovina. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Mila Kovačević, MD, PhD (+381601594444, milakov979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DoCE (Device-oriented composite endpoint) (time frame: 1 year and 2 years). 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 NCT06746233, which also lists 17 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 30 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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