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(Södersjukhuset)","Stockholm","11883",{"type":50,"coordinates":310},[311,312],18.06871,59.32938,{"lat":312,"lon":311},{"facility":315,"status":130,"city":316,"state":11,"zip":317,"country":318,"countryCode":319,"cosmosGeoPoint":320,"geoPoint":324,"contacts":11},"Belfast Health and Social Care Trust, Department of Cardiology","Belfast","BT9 7AB","United Kingdom","UK",{"type":50,"coordinates":321},[322,323],-5.92541,54.59682,{"lat":323,"lon":322},{"facility":326,"status":130,"city":327,"state":11,"zip":328,"country":318,"countryCode":319,"cosmosGeoPoint":329,"geoPoint":333,"contacts":11},"University Hospital Bristol","Bristol","BS1 3NU",{"type":50,"coordinates":330},[331,332],-2.59665,51.45523,{"lat":332,"lon":331},{"facility":335,"status":130,"city":336,"state":11,"zip":337,"country":318,"countryCode":319,"cosmosGeoPoint":338,"geoPoint":342,"contacts":11},"Barts Health NHS","London","SW17 0QT",{"type":50,"coordinates":339},[340,341],-0.12574,51.50853,{"lat":341,"lon":340},{"facility":344,"status":130,"city":336,"state":11,"zip":337,"country":318,"countryCode":319,"cosmosGeoPoint":345,"geoPoint":347,"contacts":11},"St George's University Hospital",{"type":50,"coordinates":346},[340,341],{"lat":341,"lon":340},{"type":32,"investigatorFullName":349,"investigatorTitle":350,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Evald Hoej Christiansen","Consultant MD PhD","100328992","ischemia-cto-trial---revascularisation-or-optimal-medical-therapy-of-cto-100328992",false,"NCT03563417","ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO","International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions With Myocardial Ischemia - ISCHEMIA-CTO Trial","ISCHEMIA-CTO","Inclusion Criteria:\n\n* CTO in native coronary artery\n* Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.\n* Age ≥18 yrs.\n* Able to provide written informed consent and willing to comply with the specified follow-up contacts.\n* Target artery ≥ 2.5 mm\n\nPrior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:\n\nCohort A: Asymptomatic (CCS \\\u003C 2 and SAQ QoL \\> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO\n\nCohort B: Symptomatic patients (CCS class ≥ 2 and\u002For SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO assess by nuclear imaging.\n\nCohort C: Screening population not eligible for randomization in cohort A or B\n\nExclusion Criteria:\n\n* NSTEMI or STEMI within 1 month\n* Coronary anatomy not suitable for CTO-procedure\n* Coronary disease involving the left main\u002Fthree vessel disease with indication for CABG following heart team conference.\n* Life expectancy \\\u003C 2 years\n* Severe chronic pulmonary disease (FEV1 \\\u003C 30 % of predicted value)\n* Contraindication to dual anti-platelet therapy\n* Pregnancy\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.\n* Severe valvular heart disease","ALL","18 Years",{"count":362,"type":363},1560,"ESTIMATED","INTERVENTIONAL",[366],"NA","Study design\n\nProspective randomized open labeled multicenter study\n\nHypotheses\n\n1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).\n2. In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months.\n\nInclusion Criteria\n\n* CTO in native coronary artery\n* Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.\n* Age ≥18 yrs.\n* Able to provide written Informed consent and willing to comply with the specified follow-up contacts\n* Target artery ≥ 2.5 mm\n\nPrior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:\n\nCohort A: Asymptomatic (CCS \\\u003C 2 and SAQ QoL \\> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO\n\nCohort B: Symptomatic patients (CCS class ≥ 2 and\u002For SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO\n\nCohort C: patients enrolled but not randomized in cohort A or B\n\nExclusion criteria (for both cohort A and B)\n\n* NSTEMI or STEMI within 1 month\n* Coronary anatomy not suitable for CTO-procedure\n* Coronary artery disease involving the left main\u002Fthree-vessel disease with indication for CABG following heart team conference\n* Life expectancy \\\u003C 2 years\n* Severe chronic pulmonary disease (FEV1 \\\u003C 30 % of predicted value)\n* Contraindication to dual anti-platelet therapy\n* Pregnancy\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.\n* Severe valvular heart disease\n\nPrimary endpoint\n\nCohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization\\*), hospitalization for heart failure or incidence of malignant arrhythmias.\n\n\\*CCS class ≥ 2 and\u002For QoL score \\\u003C 60. Same criteria used as for allocation to Cohort B\n\nCohort B: SAQ Quality of Life Assessment after 6 months.\n\nNumber of patients\n\n1,560 (1200 in cohort A\u002F360 in cohort B\n\nFollow up time\n\nCohort A: 5 years Cohort B: 6 months",[369,370],"Ischemic Heart Disease","Chronic Total Occlusion of Coronary Artery","2025-12-29",{"date":373,"type":374},"2026-01-02","ACTUAL",{"date":376,"type":374},"2018-11-06",{"date":378,"type":363},"2032-11-01",{"name":5,"class":6},27]