[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477065":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":67,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CS Reducer implantation","ACTIVE_COMPARATOR",null,[13,14],"Device: Coronary sinus reducer","Diagnostic Test: Invasive coronary physiology",{"label":16,"type":17,"description":11,"interventionNames":18},"Sham procedure","SHAM_COMPARATOR",[19,14],"Other: Sham-procedure",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DEVICE","Coronary sinus reducer","The Neovasc coronary sinus reducer is an hourglass-shaped stainless steel device inserted percutaneously into the coronary sinus and currently indicated for the treatment of refractory angina.",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Sham-procedure","Implantation procedure with no device implanted",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DIAGNOSTIC_TEST","Invasive coronary physiology","Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy",[9,16],[36],{"name":37,"affiliation":5,"role":38},"Ranil E de Silva, FRCP, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Ranil de Silva, FRCP, PhD","CONTACT","+44 2073518626","r.desilva@imperial.ac.uk",{"name":46,"role":42,"phone":43,"phoneExt":11,"email":47},"Kevin Cheng, BM BCh, MRCP","kevin.cheng@imperial.ac.uk",[49],{"facility":50,"status":51,"city":52,"state":11,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"National Heart and Lung Institute (Brompton Campus), Imperial College London","RECRUITING","London","SW36NP","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63,64],{"name":41,"role":42,"phone":11,"phoneExt":11,"email":44},{"name":46,"role":42,"phone":11,"phoneExt":11,"email":47},{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[68,71,73,75,77,79,81,83,85,87,89],{"name":69,"class":70},"Bradford Teaching Hospitals NHS Foundation Trust","OTHER_GOV",{"name":72,"class":70},"East and North Hertfordshire NHS Trust",{"name":74,"class":6},"Epsom and St Helier University Hospitals NHS Trust",{"name":76,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":78,"class":6},"Imperial College Healthcare NHS Trust",{"name":80,"class":6},"Kingston Hospital NHS Trust",{"name":82,"class":6},"London North West Healthcare NHS Trust",{"name":84,"class":6},"Oxford University Hospitals NHS Trust",{"name":86,"class":6},"Royal Brompton & Harefield NHS Foundation Trust",{"name":88,"class":6},"St George's University Hospitals NHS Foundation Trust",{"name":90,"class":70},"Liverpool University Hospitals NHS Foundation Trust","100477065","coronary-sinus-reducer-implantation-in-patients-with-ischaemia-and-non-obstructed-coronary-arteries-and-coronary-microvascular-dysfunction-100477065",false,"NCT05492110","Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.","REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study","REMEDY-PILOT","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose.\n3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.\n4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.\n5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).\n6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.\n7. Understands the nature of the trial procedures and provides written informed consent.\n\nExclusion Criteria:\n\n1. Epicardial CAD in a main coronary artery (stenoses \\>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI).\n2. Previous PCI within 6 months\n3. PCI with stent insertion for acute MI or chronic total occlusion (CTO)\n4. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)\n5. Coronary sinus diameter at site of implant \\\u003C9.5mm or \\>13mm\n6. Mean right atrial pressure \\\u003C15mmHg at time of implantation\n7. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\\\u003C45% by CMR.\n8. Clinically or angiographically diagnosed coronary vasospasm\n9. Previous hospitalisation for decompensated heart failure\n10. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus\n11. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator\n12. Chronic kidney disease (creatinine \\>200 micromol\u002FL; established on renal replacement therapy; functioning renal transplant)\n13. Haemoglobin \\\u003C80g\u002FL\n14. Contraindications to receiving dual antiplatelet therapy\n15. Severe chronic obstructive pulmonary disease (FEV1 \\\u003C55% predicted)\n16. Moribund patients with life expectancy \\\u003C 1year\n17. Known allergy to nickel or steel\n18. Current enrolment in another investigational device or drug trial\n19. Contraindications to CMR or receiving intravenous adenosine\n20. Pregnancy","ALL","18 Years",{"count":102,"type":103},54,"ESTIMATED","INTERVENTIONAL",[106],"NA","To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.",[109,110,111,112,113],"Refractory Angina","Microvascular Angina","Microvascular Coronary Artery Disease","Coronary Disease","Angina Pectoris",[115,116,117,118,23,119,120,121],"Angina pectoris","Refractory angina","Microvascular angina","Coronary microvascular dysfunction","Chest pain","Coronary disease","Myocardial ischaemia","2025-03-31",{"date":124,"type":125},"2025-04-03","ACTUAL",{"date":127,"type":125},"2023-04-17",{"date":129,"type":103},"2026-03-06",{"name":5,"class":6},1]