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Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy

RecruitingNAAges 18 Years - anyAllCathreine BV
NCT05731687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating dru

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📋 Eligibility rules (as published)
Inclusion Criteria: * Significant de novo bifurcation lesion (main vessel and side branch diameter ≥ 2.5mm, diameter stenosis of the main vessel ≥ 70% and of the side branch ≥ 50% or in intermediate stenosis FFR ≤ 0.80 or iFR ≤ 0.89) * Stable coronary artery disease or stabilized acute coronary syndrome * Age ≥ 18 years * Acceptable candidate for treatment with a drug eluting stent Exclusion Criteria: * Unstable clinical condition * Previous PCI with stent implantation in the target lesion(s) * Known comorbidity with a life expectancy of \<2 year * Active bleeding requiring medical attentions (BARC \>2 at index PCI) * Pregnancy * Unable to provide consent for any other reason * Participation in another stent or drug trial * Known hypersensitivity or allergy for asprin, clopidogrel, ticagrelor, prasugrel, cobalt chromium, sirolimus, to excipients with phospholipid or related origins.
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What it tests

  • Hybrid DEB approach with drug-eluting balloon
  • Two-stent strategy
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Where

1 site
Catharina Hospital
Eindhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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