Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
NCT ID: NCT05731687
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2023-03-21
2030-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hybrid DEB
Patients randomized to hybrid DEB group will receive application of DEB in the side branch.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Stable coronary artery disease or stabilized acute coronary syndrome
* Age ≥ 18 years
* Acceptable candidate for treatment with a drug eluting stent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Albert Schweitzer Hospital
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Maasstad Hospital
OTHER
The Elisabeth-TweeSteden Hospital
OTHER
St. Antonius Hospital
OTHER
Frisius Medisch Centrum
OTHER
Meander Medical Center
OTHER
VieCuri Medical Centre
OTHER
Haga Hospital
OTHER
Rijnstate Hospital
OTHER
Jeroen Bosch Ziekenhuis
OTHER
Cathreine BV
OTHER
Responsible Party
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Koen Teeuwen
Koen Teeuwen, MD, PhD, Principal Investigator
Locations
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Catharina Hospital
Eindhoven, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Koen Teeuwen, MD, PhD
Role: primary
Daimy Dillen, MD
Role: backup
References
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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.
Other Identifiers
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21112022
Identifier Type: -
Identifier Source: org_study_id