[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100176077":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":21,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":22,"enrollmentInfo":76,"targetDuration":22,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":36,"whyStopped":22,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neovasc coronary sinus reducer","EXPERIMENTAL","open label: Neovasc coronary sinus reducer",[13],"Device: Neovac coronary sinus reducer",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Neovac coronary sinus reducer","reducer",[9],[21],"Reducer",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Shmuel Banai, Prof.","CONTACT","972-3-6973395","shmuelb@tasmc.health.gov.il",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Gad Keren, Prof.","972-3-6974762","gadk@tasmc.health.gov.il",[34,50],{"facility":35,"status":36,"city":37,"state":22,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Tel Aviv Sourasky Medical Center","RECRUITING","Tel Aviv","64239","Israel","IL",{"type":42,"coordinates":43},"Point",[44,45],34.78057,32.08088,{"lat":45,"lon":44},[48,49],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":22},{"name":30,"role":26,"phone":31,"phoneExt":22,"email":22},{"facility":51,"status":36,"city":37,"state":22,"zip":22,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Tel Aviv Medical Center",{"type":42,"coordinates":53},[44,45],{"lat":45,"lon":44},[56],{"name":57,"role":26,"phone":27,"phoneExt":22,"email":58},"Shmuel Banai, Prof","shmuelb@tlvmc.gov.il",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Eli Sprecher, MD","Prof. Gad Keren",[64],{"name":65,"class":66},"Shockwave Medical, Inc.","INDUSTRY","100176077","use-of-the-neovasc-coronary-sinus-reducer-system-for-the-treatment-of-refractory-angina-pectoris-in-patients-with-ngina-class-3-4-who-are-not-candidates-for-revascularization-100176077",false,"NCT01566175","Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization","Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Angina Class 3-4 Who Are Not Candidates for Revascularization","Inclusion Criteria:\n\n* \\>18 years old\n* Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening\n* Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine\n* Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect\n\nExclusion Criteria:\n\n* Recent (within three months) acute coronary syndrome\n* Recent (within six months) PCI or CABG\n* Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening\n* De-compensated congestive heart failure or hospitalization due to CHF during the three months prior to screening\n* Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker\n* Severe chronic obstructive pulmonary disease as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value\n* Severe valvular heart disease\n* Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus\n* Patient having undergone tricuspid valve replacement or repair\n* Known allergy to stainless steel or nickel\n* Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as: Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and\u002For; CS diameter at the site of implantation\\> 12mm","ALL","18 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.",[84],"Refractory Angina",[86,87,88,89],"Neovasc Reducer","Coronary Sinus","Refractory Angina Pectoris","angina class 3-4","2022-02-01",{"date":92,"type":93},"2022-02-02","ACTUAL",{"date":95,"type":93},"2011-08-30",{"date":97,"type":78},"2031-12-31",{"name":5,"class":6},2]