[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495476":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":53,"collaborators":57,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":9,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":23,"enrollmentInfo":91,"targetDuration":23,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":36,"whyStopped":23,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Cathreine BV","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Hybrid DEB","Patients randomized to hybrid DEB group will receive application of DEB in the side branch.",[12],"Other: Hybrid DEB approach with drug-eluting balloon",{"label":14,"type":6,"description":15,"interventionNames":16},"Two-stent strategy","Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP\u002FT technique.",[17],"Other: Two-stent strategy",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"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 \\\u003C TIMI 3 flow or 70-99% residual stenosis in LM bifurcations, cross- over to two-stent technique is performed.",[9],null,{"type":6,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"When randomized to the conventional two-stent strategy, TAP\u002FT 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.",[14],[28],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"Koen Teeuwen, MD, PhD","CONTACT","040- 2398360","koen.teeuwen@catharinaziekenhuis.nl",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Catharina Hospital","RECRUITING","Eindhoven","North Brabant","5623 EJ","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],5.47778,51.44083,{"lat":46,"lon":45},[49,51],{"name":29,"role":30,"phone":50,"phoneExt":23,"email":23},"040-2398360",{"name":52,"role":30,"phone":50,"phoneExt":23,"email":23},"Daimy Dillen, MD",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Koen Teeuwen","Koen Teeuwen, MD, PhD, Principal Investigator",[58,60,62,64,66,68,70,72,74,76,78,80],{"name":59,"class":6},"Catharina Ziekenhuis Eindhoven",{"name":61,"class":6},"Albert Schweitzer Hospital",{"name":63,"class":6},"Onze Lieve Vrouwe Gasthuis",{"name":65,"class":6},"Maasstad Hospital",{"name":67,"class":6},"The Elisabeth-TweeSteden Hospital",{"name":69,"class":6},"St. Antonius Hospital",{"name":71,"class":6},"Frisius Medisch Centrum",{"name":73,"class":6},"Meander Medical Center",{"name":75,"class":6},"VieCuri Medical Centre",{"name":77,"class":6},"Haga Hospital",{"name":79,"class":6},"Rijnstate Hospital",{"name":81,"class":6},"Jeroen Bosch Ziekenhuis","100495476","bifurcation-pci-with-a-hybrid-strategy-with-drug-eluting-balloons-versus-a-stepwise-provisional-two-stent-strategy-100495476",false,"NCT05731687","Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy","Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry","Inclusion Criteria:\n\n* 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)\n* Stable coronary artery disease or stabilized acute coronary syndrome\n* Age ≥ 18 years\n* Acceptable candidate for treatment with a drug eluting stent\n\nExclusion Criteria:\n\n* Unstable clinical condition\n* Previous PCI with stent implantation in the target lesion(s)\n* Known comorbidity with a life expectancy of \\\u003C2 year\n* Active bleeding requiring medical attentions (BARC \\>2 at index PCI)\n* Pregnancy\n* Unable to provide consent for any other reason\n* Participation in another stent or drug trial\n* Known hypersensitivity or allergy for asprin, clopidogrel, ticagrelor, prasugrel, cobalt chromium, sirolimus, to excipients with phospholipid or related origins.","ALL","18 Years",{"count":92,"type":93},500,"ESTIMATED","INTERVENTIONAL",[96],"NA","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.\n\nSeveral 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.\n\nThe 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.\n\nPatients 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\u002For diminished flow \\\u003C 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.\n\nFollow-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.",[99,100],"Coronary Artery Disease","Coronary Bifurcation Lesion",[102,103,104,105],"Coronary bifurcation lesion","Coronary artery disease","Drug-eluting balloon","Percutaneous coronary intervention","2023-12-08",{"date":108,"type":109},"2023-12-15","ACTUAL",{"date":111,"type":109},"2023-03-21",{"date":113,"type":93},"2030-03",{"name":5,"class":6},1]