Bifurcation PCI with a hybrid strategy with drug eluting balloons versus a stepwise provisional two-stent strategy. A randomized controlled single-blinded multicentre trial and registry

Bifurcation PCI with a hybrid strategy with drug eluting balloons versus a stepwise provisional two-stent strategy. A randomized controlled single-blinded multicentre trial and registry - Hybrid DEB study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56240

Enrollment

640

Registered

2022-08-25

Start date

2023-03-21

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bifurcation lesions stenosis in coronary main- and sidebranch A stenosis in the coronaries where a side branch diverges from the main branch

Interventions

Patients in the hybride DEB group will get treatment with DEB in the side branch. Patients in de two-stent group will get a second stent (DES) in the side branch.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - > 18 years - Significant de novo bifurcation lesion (main branch and side branch at least 2.5mm, one or more lesions >= 70% stenosis, side branch lesion >= 50% stenosis or in case of intermediate stenosis FFR

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
To determine whether a hybrid approach with DEB is non-inferior to a two-stent strategy with respect to the primary composite end point of all cause death, periprocedural or spontaneous myocardial infarction, or target vessel revascularization at the anticipated median follow-up of 2 years, with a minimal follow-up of 1 year in each subject.	—

Secondary

Measure	Time frame
Clinical end points (measured at discharge, 12 months and at anticipated median follow-up of 2 years) • Procedural success, defined as successful stent delivery with: o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of III. o Angiographic residual diameter stenosis (DS) <=30% after PCI with DES in MV or SB and <50% after PCI with DEB in the SB. o Absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI), target vessel revascularization (TVR), stroke). • Target vessel failure (TVF, consisting of cardiac death, target vessel spontaneous MI, and TVR). • Major adverse cardiac events (MACE, consisting of all-cause death, spontaneous MI, and repeat revascularization). • Individual components of MACE and TVF. Safety endpoints during index hospitalization • Incidence of periprocedural MI • Major intraprocedural complications including type C-F dissections, perforations, slow flow or no reflow(< TIMI III), thrombus and major side branch occlusion (>2mm). • Probable and definite stent thrombosis • Major bleeding BARC type 2-5 Procedural and economical endpoints during index procedure • Contrast volume • Radiation exposure • Procedural time (time from first to last procedural angiography image) • Total costs per patient stratified to treatment group Optional Intracoronary imaging endpoints (OCT) and Intravascular Ultrasound (IVUS) if available • Percentage of stent expansion in proximal and distal Main Branch (MB) and Side-Branch (SB) • Final minimal lumen and stent area (MLA/MSA) post stenting in the proximal and distal MB and SB • Incidence and quantification of dissections in the proximal and distal MB and SB Angiographic endpoints (Core Lab Assessed): Pre-procedural assesment • MB and SB Lesion length, diameter percentage of stenosis (DS), reference vessel diameter • moderate to severe coronary calcium • Bifurcation angle • Trombus Final ass	—

Measure

Time frame

Clinical end points (measured at discharge, 12 months and at anticipated median follow-up of 2 years) • Procedural success, defined as successful stent delivery with: o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of III. o Angiographic residual diameter stenosis (DS) <=30% after PCI with DES in MV or SB and <50% after PCI with DEB in the SB. o Absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI), target vessel revascularization (TVR), stroke). • Target vessel failure (TVF, consisting of cardiac death, target vessel spontaneous MI, and TVR). • Major adverse cardiac events (MACE, consisting of all-cause death, spontaneous MI, and repeat revascularization). • Individual components of MACE and TVF. Safety endpoints during index hospitalization • Incidence of periprocedural MI • Major intraprocedural complications including type C-F dissections, perforations, slow flow or no reflow(< TIMI III), thrombus and major side branch occlusion (>2mm). • Probable and definite stent thrombosis • Major bleeding BARC type 2-5 Procedural and economical endpoints during index procedure • Contrast volume • Radiation exposure • Procedural time (time from first to last procedural angiography image) • Total costs per patient stratified to treatment group Optional Intracoronary imaging endpoints (OCT) and Intravascular Ultrasound (IVUS) if available • Percentage of stent expansion in proximal and distal Main Branch (MB) and Side-Branch (SB) • Final minimal lumen and stent area (MLA/MSA) post stenting in the proximal and distal MB and SB • Incidence and quantification of dissections in the proximal and distal MB and SB Angiographic endpoints (Core Lab Assessed): Pre-procedural assesment • MB and SB Lesion length, diameter percentage of stenosis (DS), reference vessel diameter • moderate to severe coronary calcium • Bifurcation angle • Trombus Final ass

—

Countries

Italy, Netherlands

Contacts

Public ContactD.M.M. Dillen

Catharina Ziekenhuis

daimy.dillen@catharinaziekenhuis.nl040- 2393022

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026