Coronary Artery DiseaseHybrid DEBNCT05731687
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
A study testing Hybrid DEB approach with drug-eluting balloon and Two-stent strategy in people with Coronary Artery Disease and Coronary Bifurcation Lesion, run by Cathreine BV at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Bifurcation Lesion
- What is being tested?
- Hybrid DEB approach with drug-eluting balloon and Two-stent strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2023to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Koen Teeuwen, MD, PhD, 040-2398360
Daimy Dillen, MD, 040-2398360
About this study
Official title: Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
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.
Read more
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.
- Being tested
- Hybrid DEB approach with drug-eluting balloon, Two-stent strategy
- Keywords
- Coronary bifurcation lesion, Coronary artery disease, Drug-eluting balloon, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid DEB approach with drug-eluting balloonOther
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 strategyOther
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 group | Role | What they receive |
|---|---|---|
| Hybrid DEB | Other | Patients randomized to hybrid DEB group will receive application of DEB in the side branch. Receives: Other: Hybrid DEB approach with drug-eluting balloon |
| Two-stent strategy | Other | Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique. Receives: Other: Two-stent strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
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
Measured: Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year
Secondary outcomes (31)
Procedural success
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
Measured: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Target vessel failure (TVF)
Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR at discharge, 12 months and the anticipated median 2 year
Measured: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Major adverse cardiac events (MACE)
Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization at discharge, 12 months and the anticipated median 2 year
Measured: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Individual components of MACE and TVF
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
Measured: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Periprocedural MI
Periprocedural MI within 48 hours after procedure, according to the SCAI/ARC II definition, secondary analysis according to the 4th universal definition
Measured: 48 hours after the Percutaneous Coronary Intervention (PCI)
Major intraprocedural complications
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
Measured: The end of the PCI
Probable and definite stent thrombosis
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
Measured: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Major bleeding, defined as BARC type 2-5
Major bleeding, defined as BARC type 2-5 at discharge
Measured: Discharge after the PCI
Contrast volume used during the PCI procedure
Contrast volume used during the PCI procedure (in ml)
Measured: The end of the PCI
Radiation exposure of the patient, measured in DAP and AirKerma
Radiation exposure of the patient, measured in DAP and AirKerma during the PCI procedure
Measured: The end of the PCI
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
Measured: The end of the PCI
Total procedural costs (in euro's) per patient stratified to treatment group
Total procedural costs (in euro's) per patient stratified to treatment group
Measured: 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)
Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)
Measured: 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)
Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)
Measured: The end of the PCI
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)
Measured: The end of the PCI
Core Lab Assessed initial TIMI flow main branch and side branch
Core Lab Assessed initial TIMI flow main branch and side branch
Measured: During the Coronary Angiography (CAG), before the PCI
Core Lab Assessed Lesion Length (in mm)
Core Lab Assessed Lesion Length (in mm)
Measured: During the CAG, before the PCI
Core Lab Assessed percentage diameter stenosis main branch and side branch
Core Lab Assessed percentage diameter stenosis main branch and side branch
Measured: During the CAG, before the PCI
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
Measured: During the CAG, before the PCI
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
Measured: During the CAG, before the PCI
The severity of calcification main branch and side branch, Core Lab Assessed
The severity of calcification main branch and side branch, Core Lab Assessed
Measured: During the CAG, before the PCI
Core Lab Assessed Bifurcation angle
Core Lab Assessed Bifurcation angle
Measured: During the CAG, before the PCI
Core Lab Assessed syntax I score as absolute value
Core Lab Assessed syntax I score as absolute value
Measured: During the CAG, before the PCI
Bifurcation medina score
Bifurcation medina score
Measured: During the CAG, before the PCI
Core Lab Assessed final TIMI flow main branch and side branch
Core Lab Assessed final TIMI flow main branch and side branch
Measured: 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 dissection (type A-F) after PCI in the main branch and/or side branch
Measured: The end of the PCI
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
Measured: The end of the 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
Measured: The end of the 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
Measured: 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 acute lumen gain (in mm) main of the branch and side branch after PCI
Measured: The end of the PCI
Core Lab Assessed Procedural coronary thrombus
Core Lab Assessed Procedural coronary thrombus, defined as yes or no
Measured: The end of the PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start21 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cathreine BV
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Albert Schweitzer Hospital, Onze Lieve Vrouwe Gasthuis, Maasstad Hospital, The Elisabeth-TweeSteden Hospital, St. Antonius Hospital, Frisius Medisch Centrum, Meander Medical Center, VieCuri Medical Centre, Haga Hospital, Rijnstate Hospital, Jeroen Bosch Ziekenhuis
- Responsible party
- Principal investigator, Koen Teeuwen, Cathreine BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731687
- Sponsor's protocol ID
- 21112022
- Acronym
- Hybrid DEB
- Status last verified
- Dec 2023
- First submitted
- 25 Jan 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dillen DMM, Vlaar PJ, Vermeer AJE, Paradies V, van Kuijk JP, Vink MA, Oemrawsingh RM, Hofma SH, Magro M, Remkes WS, de Smet BJGL, van Rees JB, Somi S, Halim J, Zimmermann FM, Wijnbergen IF, Tijssen JGP, Tonino PAL, Teeuwen K. Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study. Am Heart J. 2023 Dec;266:168-175. doi: 10.1016/j.ahj.2023.09.010. Epub 2023 Oct 6.
PubMed 37806333
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
- ClinicalTrials.gov ID
- NCT05731687
- Acronym / sponsor ID
- Hybrid DEB / 21112022
- Keywords
- Coronary bifurcation lesion, Coronary artery disease, Drug-eluting balloon, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cathreine BVUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Albert Schweitzer Hospital, Onze Lieve Vrouwe Gasthuis, Maasstad Hospital, The Elisabeth-TweeSteden Hospital, St. Antonius Hospital, Frisius Medisch Centrum, Meander Medical Center, VieCuri Medical Centre, Haga Hospital, Rijnstate Hospital, Jeroen Bosch Ziekenhuis
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy
| Arm | Type | Receives |
|---|---|---|
| Hybrid DEB | Other | Other: Hybrid DEB approach with drug-eluting balloonPatients randomized to hybrid DEB group will receive application of DEB in the side branch. |
| Two-stent strategy | Other | Other: Two-stent strategyPatients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid DEB approach with drug-eluting balloonIf 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 | Hybrid DEB |
| Two-stent strategyWhen 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. | Other | Two-stent strategy |
Primary outcome
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
31 secondary outcomes
Procedural success
Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Target vessel failure (TVF)
Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Major adverse cardiac events (MACE)
Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Individual components of MACE and TVF
Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Periprocedural MI
Time frame: 48 hours after the Percutaneous Coronary Intervention (PCI)
Major intraprocedural complications
Time frame: The end of the PCI
Probable and definite stent thrombosis
Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
Major bleeding, defined as BARC type 2-5
Time frame: Discharge after the PCI
Contrast volume used during the PCI procedure
Time frame: The end of the PCI
Radiation exposure of the patient, measured in DAP and AirKerma
Time frame: The end of the PCI
Procedural time, measured in minutes, defined as time from first to last procedural angiography image
Time frame: The end of the PCI
Total procedural costs (in euro's) per patient stratified to treatment group
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)
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)
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)
Time frame: The end of the PCI
Core Lab Assessed initial TIMI flow main branch and side branch
Time frame: During the Coronary Angiography (CAG), before the PCI
Core Lab Assessed Lesion Length (in mm)
Time frame: During the CAG, before the PCI
Core Lab Assessed percentage diameter stenosis 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
Time frame: During the CAG, before the PCI
Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch
Time frame: During the CAG, before the PCI
The severity of calcification main branch and side branch, Core Lab Assessed
Time frame: During the CAG, before the PCI
Core Lab Assessed Bifurcation angle
Time frame: During the CAG, before the PCI
Core Lab Assessed syntax I score as absolute value
Time frame: During the CAG, before the PCI
Bifurcation medina score
Time frame: During the CAG, before the PCI
Core Lab Assessed final TIMI flow main branch and 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
Time frame: The end of the PCI
Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI
Time frame: The end of the 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 percentage diameter stenosis main branch and side branch post 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
Time frame: The end of the PCI
Core Lab Assessed Procedural coronary thrombus
Time frame: The end of the PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 37806333Dillen DMM, Vlaar PJ, Vermeer AJE, Paradies V, van Kuijk JP, Vink MA, Oemrawsingh RM, Hofma SH, Magro M, Remkes WS, de Smet BJGL, van Rees JB, Somi S, Halim J, Zimmermann FM, Wijnbergen IF, Tijssen JGP, Tonino PAL, Teeuwen K. Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study. Am Heart J. 2023 Dec;266:168-175. doi: 10.1016/j.ahj.2023.09.010. Epub 2023 Oct 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid DEB approach with drug-eluting balloon and Two-stent strategy in people with Coronary Artery Disease and Coronary Bifurcation Lesion, run by Cathreine BV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koen Teeuwen, MD, PhD (040- 2398360, koen.teeuwen@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.