[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435008":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":27,"locations":28,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":27,"enrollmentInfo":65,"targetDuration":27,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":31,"whyStopped":27,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"CCRF Inc., Beijing, China","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravascular ultrasound guidance","EXPERIMENTAL","All targeted CTO lesions will be examined and documented using a commercially available IVUS catheter (Opticross HD) according to its instructions (if not contraindicated, preoperative vasodilation with nitroglycerin to prevent spasm).\n\nIVUS examination must be performed at least once before and after stent implantation.",[13],"Procedure: The guidewire successfully passed the CTO lesion",{"label":15,"type":16,"description":17,"interventionNames":18},"Angiographic guidance","ACTIVE_COMPARATOR","The patient will choose the appropriate length and diameter of the stent to be implanted by visual estimation. All commercially available drug-eluting stents (except first-generation DES, such as Taxus, Excel, Partner, Firebird, etc.) can be used. DES with high quality clinical evidence is strongly recommended. The type, diameter, and length of the stent are determined by the surgeon. The stent length should be selected to ensure complete coverage of the CTO lesion. If dissection is present, additional stents are implanted. Repeat angiograms were performed immediately after surgery in the same view as before surgery.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The guidewire successfully passed the CTO lesion","The successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography.\n\nAspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery.",[15,9],[26],"Load dose administration",null,[29],{"facility":30,"status":31,"city":32,"state":27,"zip":27,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"General Hospital of Shenyang Military Region","RECRUITING","Beijing","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Yaling Han","CONTACT","008602428856577","szec2005@163.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":30,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Yaling Han, M.d., Ph.D.","Academician\u002Fchief physician",[52],{"name":53,"class":54},"BSC International Medical Trading (Shanghai) Co., Ltd.","OTHER","100435008","to-evaluate-whether-ivus-guided-drug-eluting-stent-des-implantation-leads-to-better-clinical-outcomes-compared-to-conventional-angiography-in-the-treatment-of-chronic-complete-occlusion-cto-disease-100435008",false,"NCT04944615","To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.","IVUS-CTO: Comparison of the Effect of Intravascular Ultrasound-guided Versus Angiographic-guided Drug-eluting Stent Implantation on Long-term Clinical Outcomes in Patients With Chronic Complete Occlusion of Coronary Artery Disease: a Prospective, Multicenter, Randomized Controlled Clinical Study","CRUISE-CTO","Clinical inclusion criteria:\n\n1. At least 18 years old\n2. Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent\n3. Subjects with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to undergo Percutaneous coronary intervention (PCI)\n4. Subjects will receive percutaneous coronary intervention\n5. Subjects are willing to accept all treatment and follow-up evaluations required by the protocol\n\nInclusion criteria for angiography:\n\n1. Primary coronary artery CTO lesion with visible collateral circulation\n2. Estimation of the time to complete occlusion (TIMI grade 0) ≥3 months based on clinical history and\u002For comparison with historical angiography or ECG\n3. It is suitable for target lesions of 2.25-4.0mm stent implantation\n4. The length of CTO lesion should be greater than 20mm\n\nClinical exclusion criteria:\n\n1. Pregnant and lactating women\n2. Severe coronary artery disease, not suitable for PCI\n3. Patients with acute myocardial infarction less than 7 days\n4. Long-term contraindications to DAPT (at least 1 year)\n5. Known renal insufficiency.20 mL\u002Fmin \u002F 1.73 ㎡)\n6. Left ventricular ejection fraction \\<35% or cardiogenic shock\n7. The ICD implanted\u002FCRT\n8. Severe bleeding or stroke within 6 months\n9. Have a history of allergy to iodine contrast agents or any known allergy to clopidogrel, ticagrelor, aspirin, or heparin\n10. Subjects have been diagnosed or suspected of liver disease, including laboratory evidence of hepatitis\n11. Valvular heart disease significantly affecting hemodynamics, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease\n12. Diseases that researchers believe may seriously harm patients, such as cancer and mental illness;Or the patient's life expectancy is less than one year and the follow-up cannot be completed;Or other conditions that researchers think might have confounded the results\n13. Participate in any other ongoing trial or intend to participate in another clinical trial of a drug or device within 12 months after baseline surgery\n\nAngiographic exclusion criteria:\n\n1. The target lesion is located in the left main artery\n2. No visible collateral circulation in CTO lesions\n3. Target lesion is venous or arterial bypass graft\n4. The target vessel occlusion time (TIMI grade 0) \\\u003C 3 months can be determined","ALL","18 Years",{"count":66,"type":67},1448,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography",[73],"Chronic Total Occlusion of Coronary Artery",[75],"TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.","2023-03-27",{"date":78,"type":79},"2023-03-29","ACTUAL",{"date":81,"type":79},"2022-10-21",{"date":83,"type":67},"2031-10",{"name":5,"class":6},1]