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

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ClinicalTrials.gov Identifier: NCT05731687
Recruitment Status : Recruiting
First Posted : February 16, 2023
Last Update Posted : December 15, 2023
Sponsor:
Collaborators:
Catharina Ziekenhuis Eindhoven
Albert Schweitzer Hospital
Onze Lieve Vrouwe Gasthuis
Maasstad Hospital
The Elisabeth-TweeSteden Hospital
St. Antonius Hospital
Medical Centre Leeuwarden
Meander Medical Center
VieCuri Medical Centre
Haga Hospital
Rijnstate Hospital
Jeroen Bosch Ziekenhuis
Information provided by (Responsible Party):
Koen Teeuwen, Cathreine BV

Tracking Information
First Submitted Date  ICMJE January 25, 2023
First Posted Date  ICMJE February 16, 2023
Last Update Posted Date December 15, 2023
Actual Study Start Date  ICMJE March 21, 2023
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2023)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2023)		 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 or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR) at the anticipated median 2 year
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2023)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Major bleeding, defined as BARC type 2-5 [ Time Frame: Discharge after the PCI ]
    Major bleeding, defined as BARC type 2-5 at discharge
  • Contrast volume used during the PCI procedure [ Time Frame: The end of the PCI ]
    Contrast volume used during the PCI procedure (in ml)
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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
  • Core Lab Assessed Lesion Length (in mm) [ Time Frame: During the CAG, before the PCI ]
    Core Lab Assessed Lesion Length (in mm)
  • 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
  • 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
  • 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
  • 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
  • Core Lab Assessed Bifurcation angle [ Time Frame: During the CAG, before the PCI ]
    Core Lab Assessed Bifurcation angle
  • 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
  • Bifurcation medina score [ Time Frame: During the CAG, before the PCI ]
    Bifurcation medina score
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Core Lab Assessed Procedural coronary thrombus [ Time Frame: The end of the PCI ]
    Core Lab Assessed Procedural coronary thrombus, defined as yes or no
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2023)
  • 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 ≤50%) and absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, defined [ 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 ≤50%) 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
  • Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR [ 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
  • Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization [ 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
  • Individual components of MACE and TVF (All-cause death, cardiac death, periprocedural of spontaneous MI, target vessel revascularization, target vessel spontaneous MI) [ 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
  • Periprocedural MI [ Time Frame: 48 hours after the Percutaneous Coronary Intervention (PCI) ]
    Periprocedural MI within 48 hours after procedure
  • Major intraprocedural complications, defined as type C-F dissections, perforations, slow flow or no reflow (< TIMI III), thrombus, major side branch occlusion (>2mm) [ 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
  • 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 [ 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
  • Major bleeding, defined as BARC type 2-5 [ Time Frame: Discharge after the PCI ]
    Major bleeding, defined as BARC type 2-5 at discharge
  • Contrast volume used during the PCI procedure [ Time Frame: The end of the PCI ]
    Contrast volume used during the PCI procedure (in ml)
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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
  • Core Lab Assessed Lesion Length (in mm) [ Time Frame: During the CAG, before the PCI ]
    Core Lab Assessed Lesion Length (in mm)
  • 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
  • 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
  • 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
  • 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
  • Core Lab Assessed Bifurcation angle [ Time Frame: During the CAG, before the PCI ]
    Core Lab Assessed Bifurcation angle
  • 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
  • Bifurcation medina score [ Time Frame: During the CAG, before the PCI ]
    Bifurcation medina score
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Core Lab Assessed Procedural coronary thrombus [ Time Frame: The end of the PCI ]
    Core Lab Assessed Procedural coronary thrombus, defined as yes or no
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
Official Title  ICMJE Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy
Masking: Single (Participant)
Masking Description:
This is a single-blinded study. The patients are blinded for the allocated therapy
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Coronary Bifurcation Lesion
Intervention  ICMJE
  • Other: Hybrid DEB approach with drug-eluting balloon
    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.
  • Other: Two-stent strategy
    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.
Study Arms  ICMJE
  • Hybrid DEB
    Patients randomized to hybrid DEB group will receive application of DEB in the side branch.
    Intervention: Other: Hybrid DEB approach with drug-eluting balloon
  • Two-stent strategy
    Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique.
    Intervention: Other: Two-stent strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2023)		 500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2030
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Koen Teeuwen, MD, PhD 040- 2398360 koen.teeuwen@catharinaziekenhuis.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05731687
Other Study ID Numbers  ICMJE 21112022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Koen Teeuwen, Cathreine BV
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cathreine BV
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Catharina Ziekenhuis Eindhoven
  • Albert Schweitzer Hospital
  • Onze Lieve Vrouwe Gasthuis
  • Maasstad Hospital
  • The Elisabeth-TweeSteden Hospital
  • St. Antonius Hospital
  • Medical Centre Leeuwarden
  • Meander Medical Center
  • VieCuri Medical Centre
  • Haga Hospital
  • Rijnstate Hospital
  • Jeroen Bosch Ziekenhuis
Investigators  ICMJE Not Provided
PRS Account Cathreine BV
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP