[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cathreine BV\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601738","optimization-of-complex-percutaneous-coronary-intervention-with-liberal-use-of-intracoronary-imaging-versus-contemporary-practice-100601738",false,"NCT07114393","Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice","OPTIMIZE-PCI 2","Inclusion Criteria:\n\n* All patients above the age of 18, included in the Netherlands Heart Registration (NHR) quality database after receiving PCI in complex coronary lesions, will be included in the analyses of this project.\n* Meeting one or more of the following complexity criteria:\n\n  * Left main: A stenosis of \\>50% and\u002For a FFR ≤ 0.80 and iFR ≤ 0.89 in the left main.\n  * Severely calcified lesion: Defined as use of calcium modification therapy (e.g. cutting balloon, scoring balloon, rotablation, orbital atherectomy, intravascular lithotripsy).\n  * Chronic total occlusion: Coronary CTO is defined as an obstruction of the coronary artery with the following classic lesion characteristics:\n\n    * TIMI flow 0\n    * Absence of contrast stasis at the site of the proximal capillaries\n    * Presence of collateral vessels\n    * Estimated occlusion duration of at least 3 months.\n  * Ostial lesion: Lesion at the origin (within 5 mm) of a major coronary vessel (LM, LAD, RCX and RCA).\n  * Long lesion: A vessel treated with one or multiple stents with a total stent length of ≥38 mm is considered a long lesion.\n  * Bifurcation (true): A coronary artery narrowing occurring adjacent to, and\u002For involving, the origin of a significant side branch ≥ 2.5mm. Only true bifurcation will be included, i.e. medina 1,1,1\u002F1,0,1\u002F0,1,1.\n  * In-stent restenosis: A reduction ≥50% of the luminal diameter within the previously stented segment or the vessel segments 5 mm proximal and distal to the stent (the \"stent edges\"), as assessed by coronary angiography.\n\nExclusion Criteria:\n\n\\- Non complex PCI","ALL","18 Years",{"count":19,"type":20},11092,"ESTIMATED","1 Year","OBSERVATIONAL","Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction in major adverse cardiovascular events (MACE) in complex PCI. Consequently, the recommendation for intracoronary imaging has been upgraded in the most recent guidelines.\n\nDespite robust evidence supporting its benefits, intracoronary imaging remains relatively underused in real-world practice and in the Netherlands it is only used in 7% of complex PCI procedures. This underutilization may be attributed to several factors, including operator and hospital-dependent issues such as lack of experience, reluctance to spend additional time on intracoronary imaging and concerns about its cost-effectiveness. Therefore, initiating an implementation project to incorporate intracoronary imaging into routine use in the catheterization lab during complex PCI would be highly valuable. Such a project could make imaging-guided PCI the standard of care in complex PCI. Additionally, it could evaluate the cost-effectiveness of routine intracoronary imaging during complex PCI.\n\nFor this reason we designed the OPTIMIZE-PCI II, a national registry-based quality improvement project. This project is aimed at implementing a liberal intracoronary imaging-guided strategy for complex PCI across multiple centres in the Netherlands, with data extraction from the Netherlands Heart Registration (NHR) database. The objective of the OPTIMIZE-PCI II is to establish a routine use of intracoronary imaging in complex PCI, to determine if this approach reduces adverse cardiac events in real-world practice, and evaluate its cost-effectiveness.",[25,26,27,28],"Coronary Artery Disease","Coronary Artery Disease (Left Main)","Chronic Total Occlusion (CTO)","Bifurcation Coronary Artery Disease",[30,31,32,33],"percutaneous coronary intervention","intracoronary imaging","stent optimization","complex coronary artery disease","RECRUITING","2026-03-24",{"date":37,"type":38},"2026-03-27","ACTUAL",{"date":40,"type":38},"2025-04-01",{"date":42,"type":20},"2027-05-01",{"name":44,"class":45},"Cathreine BV","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100559003","optimization-of-percutaenous-coronary-intervention-with-liberal-use-of-post-dilatation-100559003","NCT06558474","Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation","Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice","OPTIMIZE-PCI","Inclusion Criteria:\n\n* All patients \\>18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project\n\nExclusion Criteria:\n\n\\- If a patient has multiple PCIs within 365 days, only the first procedure is included.",{"count":56,"type":20},12000,"To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment.\n\nPost-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear.\n\nFor this reason, the OPTIMIZE PCI was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.",[25],[30,60,32,61],"coronary artery disease","post-dilatation","2025-08-04",{"date":64,"type":38},"2025-08-07",{"date":66,"type":38},"2023-09-01",{"date":68,"type":20},"2026-05-01",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"100495476","bifurcation-pci-with-a-hybrid-strategy-with-drug-eluting-balloons-versus-a-stepwise-provisional-two-stent-strategy-100495476","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","Hybrid DEB","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.",{"count":79,"type":20},500,"INTERVENTIONAL",[82],"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.",[25,85],"Coronary Bifurcation Lesion",[87,88,89,90],"Coronary bifurcation lesion","Coronary artery disease","Drug-eluting balloon","Percutaneous coronary intervention","2023-12-08",{"date":93,"type":38},"2023-12-15",{"date":95,"type":38},"2023-03-21",{"date":97,"type":20},"2030-03",{"name":44,"class":45},""]