search
Back to results

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

Primary Purpose

Coronary Artery Disease, Coronary Bifurcation Lesion

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hybrid DEB approach with drug-eluting balloon
Two-stent strategy
Sponsored by
Cathreine BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary bifurcation lesion, Coronary artery disease, Drug-eluting balloon, Percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Significant de novo bifurcation lesion 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.

Sites / Locations

  • Catharina HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hybrid DEB

Two-stent strategy

Arm Description

Patients randomized to hybrid DEB group will receive application of DEB in the side branch.

Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique.

Outcomes

Primary Outcome Measures

Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR) at the anticipated median 2 year

Secondary Outcome Measures

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
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
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
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)
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
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)
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
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
Major bleeding, defined as BARC type 2-5 at discharge
Contrast volume used during the PCI procedure
Contrast volume used during the PCI procedure (in ml)
Radiation exposure of the patient, measured in DAP and AirKerma
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
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
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)
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)
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)
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
Core Lab Assessed initial TIMI flow main branch and side branch
Core Lab Assessed Lesion Length (in mm)
Core Lab Assessed Lesion Length (in mm)
Core Lab Assessed percentage diameter stenosis main branch and side branch
Core Lab Assessed percentage diameter stenosis main branch and side branch
Core Lab Assessed reference diameter (in mm) proximal main branch and side branch
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
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
The severity of calcification main branch and side branch, Core Lab Assessed
Core Lab Assessed Bifurcation angle
Core Lab Assessed Bifurcation angle
Core Lab Assessed syntax I score as absolute value
Core Lab Assessed syntax I score as absolute value
Bifurcation medina score
Bifurcation medina score
Core Lab Assessed final TIMI flow main branch and side branch
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
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
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
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
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
Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI
Core Lab Assessed Procedural coronary thrombus
Core Lab Assessed Procedural coronary thrombus, defined as yes or no

Full Information

First Posted
January 25, 2023
Last Updated
March 27, 2023
Sponsor
Cathreine BV
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05731687
Brief Title
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Conventional Two-stent Strategy
Acronym
Hybrid DEB
Official Title
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Conventional Two-stent Strategy A Randomized Controlled Trial and Registry
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cathreine BV
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 bailout two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and bailout) 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 conventional 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Bifurcation Lesion
Keywords
Coronary bifurcation lesion, Coronary artery disease, Drug-eluting balloon, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy
Masking
Participant
Masking Description
This is a single-blinded study. The patients are blinded for the allocated therapy
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid DEB
Arm Type
Other
Arm Description
Patients randomized to hybrid DEB group will receive application of DEB in the side branch.
Arm Title
Two-stent strategy
Arm Type
Other
Arm Description
Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique.
Intervention Type
Other
Intervention Name(s)
Hybrid DEB approach with drug-eluting balloon
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Two-stent strategy
Intervention Description
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 Outcome Measure Information:
Title
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
Description
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR) at the anticipated median 2 year
Time Frame
Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Title
Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR
Description
Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR at discharge, 12 months and the anticipated median 2 year
Time Frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Title
Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization
Description
Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization at discharge, 12 months and the anticipated median 2 year
Time Frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Title
Individual components of MACE and TVF (All-cause death, cardiac death, periprocedural of spontaneous MI, target vessel revascularization, target vessel spontaneous MI)
Description
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
Time Frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Title
Periprocedural MI
Description
Periprocedural MI within 48 hours after procedure
Time Frame
48 hours after the Percutaneous Coronary Intervention (PCI)
Title
Major intraprocedural complications, defined as type C-F dissections, perforations, slow flow or no reflow (< TIMI III), thrombus, major side branch occlusion (>2mm)
Description
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
Time Frame
The end of the PCI
Title
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
Description
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
Time Frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Title
Major bleeding, defined as BARC type 2-5
Description
Major bleeding, defined as BARC type 2-5 at discharge
Time Frame
Discharge after the PCI
Title
Contrast volume used during the PCI procedure
Description
Contrast volume used during the PCI procedure (in ml)
Time Frame
The end of the PCI
Title
Radiation exposure of the patient, measured in DAP and AirKerma
Description
Radiation exposure of the patient, measured in DAP and AirKerma during the PCI procedure
Time Frame
The end of the PCI
Title
Procedural time, measured in minutes, defined as time from first to last procedural angiography image
Description
Procedural time, measured in minutes, defined as time from first to last procedural angiography image
Time Frame
The end of the PCI
Title
Total procedural costs (in euro's) per patient stratified to treatment group
Description
Total procedural costs (in euro's) per patient stratified to treatment group
Time Frame
The end of the PCI
Title
Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)
Description
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
Title
Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)
Description
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
Title
Dissections in the proximal and distal main branch and side branch, measured using intracoronary imaging (OCT or IVUS)
Description
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
Title
Core Lab Assessed initial TIMI flow main branch and side branch
Description
Core Lab Assessed initial TIMI flow main branch and side branch
Time Frame
During the Coronary Angiography (CAG), before the PCI
Title
Core Lab Assessed Lesion Length (in mm)
Description
Core Lab Assessed Lesion Length (in mm)
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed percentage diameter stenosis main branch and side branch
Description
Core Lab Assessed percentage diameter stenosis main branch and side branch
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed reference diameter (in mm) proximal main branch and side branch
Description
Core Lab Assessed reference diameter (in mm) proximal main branch and side branch
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch
Description
Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch
Time Frame
During the CAG, before the PCI
Title
The severity of calcification main branch and side branch, Core Lab Assessed
Description
The severity of calcification main branch and side branch, Core Lab Assessed
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed Bifurcation angle
Description
Core Lab Assessed Bifurcation angle
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed syntax I score as absolute value
Description
Core Lab Assessed syntax I score as absolute value
Time Frame
During the CAG, before the PCI
Title
Bifurcation medina score
Description
Bifurcation medina score
Time Frame
During the CAG, before the PCI
Title
Core Lab Assessed final TIMI flow main branch and side branch
Description
Core Lab Assessed final TIMI flow main branch and side branch
Time Frame
The end of the PCI
Title
Core Lab Assessed residual dissection (type A-F) after PCI in the main branch and/or side branch
Description
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
Title
Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI
Description
Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI
Time Frame
The end of the PCI
Title
Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI
Description
Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI
Time Frame
The end of the PCI
Title
Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI
Description
Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI
Time Frame
The end of the PCI
Title
Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI
Description
Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI
Time Frame
The end of the PCI
Title
Core Lab Assessed Procedural coronary thrombus
Description
Core Lab Assessed Procedural coronary thrombus, defined as yes or no
Time Frame
The end of the PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Significant de novo bifurcation lesion 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Teeuwen, MD, PhD
Phone
040- 2398360
Email
koen.teeuwen@catharinaziekenhuis.nl
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
North- Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Teeuwen, MD, PhD
Phone
040-2398360
First Name & Middle Initial & Last Name & Degree
Daimy Dillen, MD
Phone
040-2398360

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs