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NCT Number: NCT05731687

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

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 drug, which is released into the vessel wall during inflation.

Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies.

The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach.

Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow < Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry.

Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Bifurcation Lesion Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location status: Recruiting

Location contact

Daimy Dillen, MD

CONTACT

040-2398360

Koen Teeuwen, MD, PhD

CONTACT

040-2398360

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid DEB approach with drug-eluting balloon

Other

If a patient is randomized to the hybrid DEB approach, lesion preparation of the SB with non-compliant balloon (NC) is mandatory before DEB application. The application of DEB can be performed if acceptable result of the lesion preparation is obtained (at least TIMI III flow and no flow limiting dissection). The drug- eluting balloon used in this study is the CE- marked Magic Touch Sirolimus Coated Balloon Catheter (Concept Medical, Gujarat, India). The size of the DEB is measured on a ratio 1:1 on reference diameter of the SB. The DEB balloon is inflated for 60 seconds, or two times more than 30 seconds if long duration inflations are not possible. Finally low pressure kissing inflation with the same DEB in place, and Proximal Optimization Therapy (POT) are performed. In case of SB occlusion, or flow limiting dissections in non-Left Main (LM) bifurcations and < TIMI 3 flow or 70-99% residual stenosis in LM bifurcations, cross- over to two-stent technique is performed.

Two-stent strategy

Other

When randomized to the conventional two-stent strategy, TAP/T or Culotte stenting is performed. First lesion preparation of the SB is mandatory. The drug-eluting stent (Supraflex stent) can be placed in the SB if acceptable result of the lesion preparation is obtained and is measured on a 1:1 ratio on reference diameter of the SB. Finally, kissing inflation and POT are mandatory.

Primary outcomes

  1. Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)

    Time frame: Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year

    Composite of all-cause death, periprocedural (according to the SCAI/ARC II definition and a secondary analysis according to the 4th universal definition) or spontaneous (according to the 4th universal definition) myocardial infarction (MI) and/or target vessel revascularization (TVR) at the anticipated median 2 year

Secondary outcomes

  1. Procedural success

    Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

    Procedural success defined as successful stent delivery with final core lab (defined as TIMI flow of III, angiographic in-stent MB and SB diameter stenosis ≤30%, or ≤50% after DEB in the side branch) and absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, defined as all cause death, spontaneous MI, TVR, stoke) at discharge, 12 months and the anticipated median 2 year

  2. Target vessel failure (TVF)

    Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

    Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR at discharge, 12 months and the anticipated median 2 year

  3. Major adverse cardiac events (MACE)

    Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

    Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization at discharge, 12 months and the anticipated median 2 year

  4. Individual components of MACE and TVF

    Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

    Individual components of MACE and TVF (All-cause death, cardiac death, periprocedural of spontaneous MI, target vessel revascularization, target vessel spontaneous MI) at discharge, 12 months and the anticipated median 2 year

  5. Periprocedural MI

    Time frame: 48 hours after the Percutaneous Coronary Intervention (PCI)

    Periprocedural MI within 48 hours after procedure, according to the SCAI/ARC II definition, secondary analysis according to the 4th universal definition

  6. Major intraprocedural complications

    Time frame: The end of the PCI

    Major intraprocedural complications, defined as type C-F dissections, perforations, slow flow or no reflow (< TIMI III), thrombus, major side branch occlusion (>2mm) during the index procedure

  7. Probable and definite stent thrombosis

    Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

    Probable and definite stent thrombosis, defined as Angiographic confirmation of stent thrombosis, or any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause at discharge, 12 months and the anticipated median 2 year

  8. Major bleeding, defined as BARC type 2-5

    Time frame: Discharge after the PCI

    Major bleeding, defined as BARC type 2-5 at discharge

  9. Contrast volume used during the PCI procedure

    Time frame: The end of the PCI

    Contrast volume used during the PCI procedure (in ml)

  10. Radiation exposure of the patient, measured in DAP and AirKerma

    Time frame: The end of the PCI

    Radiation exposure of the patient, measured in DAP and AirKerma during the PCI procedure

  11. Procedural time, measured in minutes, defined as time from first to last procedural angiography image

    Time frame: The end of the PCI

    Procedural time, measured in minutes, defined as time from first to last procedural angiography image

  12. Total procedural costs (in euro's) per patient stratified to treatment group

    Time frame: The end of the PCI

    Total procedural costs (in euro's) per patient stratified to treatment group

  13. Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)

    Time frame: The end of the PCI

    Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)

  14. Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)

    Time frame: The end of the PCI

    Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)

  15. Dissections in the proximal and distal main branch and side branch, measured using intracoronary imaging (OCT or IVUS)

    Time frame: The end of the PCI

    Dissections in the proximal and distal main branch and side branch, measured using intracoronary imaging (OCT or IVUS)

  16. Core Lab Assessed initial TIMI flow main branch and side branch

    Time frame: During the Coronary Angiography (CAG), before the PCI

    Core Lab Assessed initial TIMI flow main branch and side branch

  17. Core Lab Assessed Lesion Length (in mm)

    Time frame: During the CAG, before the PCI

    Core Lab Assessed Lesion Length (in mm)

  18. Core Lab Assessed percentage diameter stenosis main branch and side branch

    Time frame: During the CAG, before the PCI

    Core Lab Assessed percentage diameter stenosis main branch and side branch

  19. Core Lab Assessed reference diameter (in mm) proximal main branch and side branch

    Time frame: During the CAG, before the PCI

    Core Lab Assessed reference diameter (in mm) proximal main branch and side branch

  20. Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch

    Time frame: During the CAG, before the PCI

    Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch

  21. The severity of calcification main branch and side branch, Core Lab Assessed

    Time frame: During the CAG, before the PCI

    The severity of calcification main branch and side branch, Core Lab Assessed

  22. Core Lab Assessed Bifurcation angle

    Time frame: During the CAG, before the PCI

    Core Lab Assessed Bifurcation angle

  23. Core Lab Assessed syntax I score as absolute value

    Time frame: During the CAG, before the PCI

    Core Lab Assessed syntax I score as absolute value

  24. Bifurcation medina score

    Time frame: During the CAG, before the PCI

    Bifurcation medina score

  25. Core Lab Assessed final TIMI flow main branch and side branch

    Time frame: The end of the PCI

    Core Lab Assessed final TIMI flow main branch and side branch

  26. Core Lab Assessed residual dissection (type A-F) after PCI in the main branch and/or side branch

    Time frame: The end of the PCI

    Core Lab Assessed residual dissection (type A-F) after PCI in the main branch and/or side branch

  27. Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI

    Time frame: The end of the PCI

    Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI

  28. Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI

    Time frame: The end of the PCI

    Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI

  29. Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI

    Time frame: The end of the PCI

    Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI

  30. Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI

    Time frame: The end of the PCI

    Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI

  31. Core Lab Assessed Procedural coronary thrombus

    Time frame: The end of the PCI

    Core Lab Assessed Procedural coronary thrombus, defined as yes or no

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Teeuwen, MD, PhD

CONTACT

[email protected]

040- 2398360

Sponsors and collaborators

Lead sponsor

Cathreine BV

Other

Collaborators

  • Albert Schweitzer Hospital
  • Catharina Ziekenhuis Eindhoven
  • Frisius Medisch Centrum
  • Haga Hospital
  • Jeroen Bosch Ziekenhuis
  • Maasstad Hospital
  • Meander Medical Center
  • Onze Lieve Vrouwe Gasthuis
  • Rijnstate Hospital
  • St. Antonius Hospital
  • The Elisabeth-TweeSteden Hospital
  • VieCuri Medical Centre

Registry information

Official study title

Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry

Acronym: Hybrid DEB

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Feb 16, 2023
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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