[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-angina\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-angina":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,70,97,131,154],{"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":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100447098","efficacy-of-the-coronary-sinus-reducer-in-patients-with-refractory-angina-ii-100447098",false,"NCT05102019","Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II","COSIRA-II","Inclusion Criteria:\n\n1. Subject is older than 18 years of age\n2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea\n3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify\n4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee\n5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved tests (such as diastolic hyperaemia free ratio \\[DRF\\] or resting full-cycle ratio \\[RFR\\] in the distribution of the left coronary artery (LCA), performed within 12 months prior to enrollment Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 10 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications Note: The ETT variability must be less than 20% between last two ETTs performed.\n7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to enrollment Note: The LVEF must be reassessed after any intervening myocardial infarction. For subjects with multiple assessments, the most recent LVEF assessment is used as the qualifying test.\n8. Subject is willing and able to sign informed consent\n9. Subject is willing to comply with the specified follow-up evaluations\n\nAngiographic Inclusion Criteria:\n\n1\\) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50% - \\\u003C70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved\u002Fcleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the left coronary artery (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI, or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study\n\nExclusion Criteria:\n\n1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled\n2. Recent successful revascularization by either CABG or PCI within six months prior to enrollment\n\n   Note: Successful revascularization is defined as any CABG procedure, or any PCI procedure with a reduction of one or more lesions to \\\u003C50% diameter stenosis\n\n   Note: Subjects with successful revascularization by either CABG or PCI that occurred less than six months prior to enrollment may still be approved for participation in the trial if revascularization was completed six months prior to procedure and CSEC approves subject participation\n3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment\n\n   Note: Subjects with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be approved for participation in the trial if PCI was completed 30 days prior to procedure and CSEC approves subject participation\n4. The predominant manifestation of angina is dyspnea\n\n   Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity must be angina (i.e., chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location)\n5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \\\u003C10 g\u002FdL), uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \\>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), or epicardial vasospasm disease\u002Fcoronary artery vasospasm (CAS)\u002Fvasospastic angina (VSA)\n6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment\n7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and\u002For pacemaker\n8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids\n9. Severe valvular heart disease (any valve)\n10. Moderate or severe RV dysfunction by echocardiography\n11. Pacemaker electrode\u002Flead is present in the coronary sinus\n12. A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF\u002FAHA\u002FHRS guidelines\n13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment\n14. Chronic severe renal failure (estimated eGFR less than 30 mL\u002Fmin\u002F1.73m2 by the MDRD formula) or subjects on chronic dialysis\n15. Known allergy to stainless steel or nickel\n16. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of procedure)\n17. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures\n18. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the procedure)\n19. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.\n20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant\n21. Comorbidities limiting life expectancy to less than one year\n22. Subject is currently hospitalized for definite or suspected COVID-19\n23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been asymptomatic for \\\u003C8 weeks prior to enrollment or has not returned to his or her prior baseline (pre-COVID-19) clinical condition\n24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within the past 4 weeks prior to enrollment\n\nAngiographic\u002FHemodynamic Exclusion Criteria:\n\n1\\) Coronary anatomy amenable to revascularization of ischemic myocardial territory by either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or angina equivalent symptoms, as per the assessment of the local heart team.\n\nNote: If a pathway to coronary revascularization is present which, in the opinion of the local heart team, is reasonably low risk and reasonably likely to provide long-term symptom relief and the subject refuses the revascularization procedure, the patient is ineligible for randomization\n\nProcedural Angiographic\u002FHemodynamic Randomization Exclusion Criteria:\n\n1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization\n2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \\[SVC\\]) as demonstrated by angiogram\n3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm\n\nSingle-arm Registry (Unblinded, Non-Randomized Treatment Arm) Inclusion\u002FExclusion Criteria:\n\nSubject can be included in the single-arm registry if they fall into one of the three categories with inclusions and exclusion criteria as described below.\n\nPredominant right coronary disease subjects (RCA):\n\n1. Reversible ischemia: Subjects with evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved or cleared tests (such as DFR or RFR) in the distribution of the right coronary artery (RCA), performed within 12 months prior to enrollment.\n\n   Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the RCA distribution\n\n   Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. If the anti-anginal medication regimen is permanently changed after the assessment of ischemia, the test must be repeated. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n2. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis of ≥70% or ≥50% - \\\u003C70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved\u002Fcleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the RCA (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team.\n\n   Note: The qualifying assessment must be performed after any myocardial infarction, PCI or CABG within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study\n3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial\n\nNon-obstructive coronary artery disease subjects (ANOCA)\n\n1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (\\\u003C 2.0), abnormal perfusion CMR (cardiac MRI) CFR (\\\u003C1.85), or abnormal invasive CFR (\\\u003C2.5) in at least one main epicardial coronary artery performed within 12 months prior to enrollment\n\n   Note: Subjects may or may not have evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, or CT perfusion\n2. Non-obstructive CAD: subjects have non-obstructive coronary disease (estimated diameter stenosis in all coronary lesions is \\\u003C50% and (if performed) FFR ≥0.81 or a non-hyperemic test is ≥0.90) demonstrated on three-vessel coronary angiography performed within the 12 months prior to enrollment. If an estimated diameter stenosis is ≥50% to \\\u003C70%, the patient may still qualify if FFR ≥0.81 or a non-hyperemic test is ≥0.90 in that vessel. If both FFR and a non-hyperemic test are performed, both must be negative.\n\n   Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study\n3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial\n\nSubjects unable to complete ETT\n\n1. Subjects must be unable to complete the required COSIRA-II exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid (e.g., wheelchair, cane, rollator, crutches, or knee walker).\n2. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main randomized trial\n\nPrior to inclusion in single-arm registry, all subjects will be reviewed by the Central Screening Eligibility Committee to ensure that they meet registry inclusion criteria and are not eligible for enrollment into the randomized study.","ALL","18 Years",{"count":19,"type":20},380,"ESTIMATED","INTERVENTIONAL",[23],"NA","To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.",[26],"Refractory Angina","RECRUITING","2026-04-20",{"date":30,"type":31},"2026-04-22","ACTUAL",{"date":33,"type":31},"2022-01-04",{"date":35,"type":20},"2032-01",{"name":37,"class":38},"Shockwave Medical, Inc.","INDUSTRY",95,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100493952","phase-2-assessing-the-safety-and-effectiveness-of-intracoronary-stem-cells-in-patients-with-refractory-angina-100493952","NCT05711849","Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina","A Phase II Randomised Sham-controlled Trial Assessing the Safety and Efficacy of Intracoronary Administration of Autologous Bone Marrow Cells in Patients With Refractory Angina","RegenCobra","Inclusion Criteria:\n\n1. Subject is older than 18 years of age\n2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy\n3. Must have attempted treatment with the maximally tolerated dose of at least two of the four approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for greater than 2 months prior to enrolment, with no intent to change the medical regimen for at least 12 months after randomisation\n4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization\n5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR, iFR, or other non-hyperaemic tests.\n6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 8 minutes\n7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12- months prior to procedure (must be reassessed after any intervening myocardial infarction); the most recent LVEF assessment is used as the qualifying test\n8. Subject is willing and able to sign informed consent\n9. Subject is willing to comply with the specified follow-up evaluations\n\nExclusion Criteria:\n\n1. Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI).\n2. Recent successful revascularization by CABG or PCI within six months prior to enrolment\n3. Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30 days prior to enrolment\n4. The predominant manifestation of angina is dyspnoea\n5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, anaemia (hgb \\\u003C10 g\u002FdL), uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \\>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), etc.\n6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalisation due to HF during the 90 days prior to enrolment\n7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and\u002For pacemaker\n8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids\n9. Severe valvular heart disease (any valve)\n10. Moderate or severe RV dysfunction by echocardiography\n11. Chronic severe renal failure (estimated eGFR less than 30 mL\u002Fmin\u002F1.73m2 by the MDRD formula)\n12. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, etc.)\n13. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures\n14. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the randomisation procedure)\\*\n15. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.\n16. Inability to tolerate dual antiplatelet therapy for 1 month if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 1 month if on a chronic oral anticoagulant\n17. Comorbidities limiting life expectancy to less than one year if recorded in patient's notes\n18. Documented acute infection in patient's notes\n19. Immunosuppressive medication\n20. Inability to understand written and verbal English",{"count":49,"type":20},110,[51],"PHASE2","REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in.\n\nIn the 'treatment' group:\n\n* Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration).\n* Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin.\n* The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.\n\nIn the 'sham' group:\n\n* A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic.\n* A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic.\n* The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.",[54,26],"Refractory Angina Pectoris",[56,57,58],"Angina","Autologous stem cells","Stem cells","2026-01-05",{"date":61,"type":31},"2026-01-07",{"date":63,"type":31},"2024-03-01",{"date":65,"type":20},"2026-08-31",{"name":67,"class":68},"Barts & The London NHS Trust","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":69},"100596694","phase-2-investigational-trial-to-evaluate-xc001-delivered-via-an-cardiac-catheter-in-subjects-with-chronic-angina-100596694","NCT07048808","Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.","Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (With 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety","EXACT2","Inclusion Criteria:\n\n1. Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.\n2. Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined by ESC Joint Study Group on the Treatment of Refractory Angina Refractory, Mannheimer et al, EHJ 2002 and the 2013 ESC guidelines on the management of stable coronary artery disease, Montalescot et al, EHJ 2013; and Jolicoeur et al 2008).\n3. Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.\n4. History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- photon emission computed tomography (SPECT), CT angiography imaging with fractional flow reserve analysis, stress PET (including screening) or cardiac magnetic resonance (CMR) imaging that has not resolved with intervention or by an acute coronary event.\n5. Coronary angiography (and\u002For computed tomography (coronary) angiography (CTA)) within the past 18 months unless there is a clinical indication to warrant a more current procedure as determined by the investigator.\n6. Two baseline ECG stress tests (treadmill test, modified Bruce protocol) that adhere to the following (details outlined in the ETT manual):\n\n   i. A modified Bruce protocol that includes two three-minute warm- up stages of 1.7 mph\u002F 0% grade and 1.7 mph\u002F 5% grade.\n\n   ii. TED of 90 seconds to 9.5 minutes that is limited\u002Fstopped because of angina (or angina equivalent).\n\n   iii. The maximally allowed variation between two subsequent treadmill tests should not exceed 25% and should not exceed 75 seconds. The ETT core laboratory must review and approve the ETTs for eligibility.\n\n   iv. The tests must be performed at least 48 hours apart from each other. v. A third test is permitted if the second test does not meet the criteria.\n7. On a stable regimen of anti-anginal, anti-hypertensive, and lipid lowering medications deemed medically appropriate for RA at the discretion of the investigator. The chronic anti-anginal regimen must include at least two functional classes at the maximally tolerated dose for the preceding 30 days prior to the screening visit (Jolicoeur 2008). Functional classes include beta-blockers, calcium channel blockers, (long-acting) nitrates, and metabolic modulators (i.e., ranolazine, trimetazidine, ivabradine, nicorandil). Use of fewer than two functional classes may be allowed if there is evidence of intolerance to those classes of anti-anginal medications.\n8. Formally approved by the ERC to undergo the study procedure by a review of past medical history and screening assessments, with emphasis on reversible left ventricular ischemia (further details provided in the ERC Charter).\n9. All subjects capable of procreation with their partners must agree to use a highly effective and medically accepted method of contraception for 6 months following the study procedure (Day 1) to avoid pregnancy (as defined in Appendix A). This is not required of female subjects who are either:\n\n   * Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal contraception or hormonal replacement therapy; OR\n   * Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening\n10. Female subjects agree to not donate oocytes and male subjects must agree not to donate sperm for 6 months following administration of the investigational product (IP).\n11. Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.\n\nExclusion Criteria:\n\n1. Any of the following:\n\n   1. ST-Elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) not requiring revascularization, transmural MI, or cerebral vascular accident within the past 60 days prior to the screening visit.\n   2. Uncontrolled hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg\u002FdL.\n   3. Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\>180 mmHg, diastolic BP \\>100 mmHg) despite maximal medical treatment.\n   4. Current untreated malignant ventricular arrhythmias (with episode of sustained or non-sustained ventricular tachycardia (VT) in last 30 days; suspected\u002Fprobable\u002Fdefinite).\n   5. Current untreated bradyarrhythmia (\\\u003C50 bpm) for which a new artificial pacemaker placement is anticipated during the study period. A current pacemaker is allowed.\n   6. Congestive heart failure defined as New York Heart Association Function Class III or IV or left ventricular ejection fraction \\\u003C 25% within the 6 weeks prior to the screening visit (or as assessed by the screening contrast Echo).\n   7. Anginal episodes that routinely require the administration of opiates.\n2. Moderate to severe aortic valve stenosis (defined as Doppler echocardiography determined peak pressure gradient that exceeds 40 mm Hg (or Vmax \\>3.2 m\u002Fs) and\u002For subjects with a mechanical valve in the aorta valve position.\n3. Presence of a ventricular thrombus (as defined by contrast transthoracic echocardiography at screening). Subjects may be rescreened after 6 weeks of adequate treatment and absence of ventricular thrombus by echocardiography.\n4. Body mass index \\> 45 kg\u002Fm2.\n5. Hemoglobin \\\u003C 10 g\u002FdL, absolute neutrophil count \\\u003C 1.2 × 103 per µL, platelet count \\\u003C 75,000 per µL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), total bilirubin \\> 2 x ULN unless the subject has a previously known history of Gilbert's syndrome and estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n6. Diabetic with current glycosylated hemoglobin (HbA1c) \\> 9.5% or active proliferative diabetic retinopathy.\n7. Documented active proliferative retinopathy from any cause (ETDRS \\[Early Treatment Diabetic Retinopathy Study\\] score \\>35).\n8. Uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy)\n9. Patients with unstable chronic obstructive pulmonary disease despite adequate treatment.\n10. A history or evidence of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV), or active hepatitis B virus (HBV).\n11. Severely immuno-compromised patients, including high-dose chronic corticosteroid therapy or cytostatic (oncolytic) therapy.\n12. Diagnosis of, or treatment for, any cancer within the last 5 years except for cutaneous basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. (Past medical history of cancer is not exclusionary if the subject has been disease free for at least 5 years since the end of treatment).\n13. Known hypersensitivity or any other contraindication to adenosine, regadenoson, or contrast agents used in any of the radiographic procedures or contraindication to anesthesia employed for the study procedure.\n14. Pregnancy or currently lactating.\n15. Receiving an investigational intervention or participating in another clinical trial within 30 days or within 5 half-lives of the drug prior to screening. Exception may be made if the individual is enrolled in a non- therapeutic observational study (registry) or the observational portion of a therapeutic study where the sponsoring authority authorizes enrollment.\n16. Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the subject was randomized to the placebo control group and did not receive active gene transfer agent, the subject may be considered for this study. Has a serious or unstable medical or psychological condition (including drug or alcohol abuse) or other circumstance that, in the opinion of the investigator or ERC, would compromise the subject's safety or successful participation in the study or interpretation of study results. In particular, any suspected drug-seeking behavior related to chest pain should be exclusionary.\n17. Known allergy to nickel.","85 Years",{"count":80,"type":20},106,[51],"This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD.\n\nPart 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study.\n\nPart 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.",[26,84],"Coronary Artery Disease",[56,86,87],"EXACT 2","Refractory angina","2025-07-30",{"date":90,"type":31},"2025-08-03",{"date":92,"type":31},"2025-06-24",{"date":94,"type":20},"2027-06-30",{"name":96,"class":38},"XyloCor Therapeutics, Inc.",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":69},"100477065","coronary-sinus-reducer-implantation-in-patients-with-ischaemia-and-non-obstructed-coronary-arteries-and-coronary-microvascular-dysfunction-100477065","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",{"count":106,"type":20},54,[23],"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.",[26,110,111,112,113],"Microvascular Angina","Microvascular Coronary Artery Disease","Coronary Disease","Angina Pectoris",[115,87,116,117,118,119,120,121],"Angina pectoris","Microvascular angina","Coronary microvascular dysfunction","Coronary sinus reducer","Chest pain","Coronary disease","Myocardial ischaemia","2025-03-31",{"date":124,"type":31},"2025-04-03",{"date":126,"type":31},"2023-04-17",{"date":128,"type":20},"2026-03-06",{"name":130,"class":68},"Imperial College London",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":69},"100409051","cosima-coronary-sinus-reducer-for-the-treatment-of-refractory-microvascular-angina-100409051","NCT04606459","COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina","A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina","COSIMA","Inclusion Criteria:\n\n* Age ≥ 18 and ≤85 years\n* Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy\n* Evidence of reversible ischemia on non-invasive testing\n* Evidence of microvascular disease as diagnosed invasively by at least one of the following:\n\n  1. index of microvascular resistances (IMR) \\>25 and\u002For\n  2. coronary flow reserve (CFR) \\\u003C2.0) with fractional flow reserve (FFR)\\>0.8.\n* Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.\n\nExclusion Criteria:\n\nSubjects presenting at least one of the following criteria will not be enrolled in the trial\n\n* Recent (within 3 months) acute coronary syndrome\n* Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG)\n* Recent (within 30 days) unsuccessful PCI\n* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months\n* Left ventricular ejection fraction of \\\u003C30%\n* Mean right atrial pressure \\>15mmHg\n* Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \\[SVC\\]) as demonstrated by angiogram\n* CS diameter at the site of planned Reducer implantation greater than 13mm or less than 9.5mm as measured by angiogram\n* Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value\n* Severe valvular heart disease\n* A pacemaker electrode in the coronary sinus\n* Tricuspid valve replacement or repair\n* Chronic renal failure (serum creatinine \\>2mg\u002FdL), and\u002For on chronic hemodialysis\n* Moribund, or with comorbidities limiting life expectancy to less than one year\n* Known severe reaction to required procedural medications\n* Known allergy to stainless steel or nickel\n* Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation\n* Contraindication to dual antiplatelet therapy\n* Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy)",{"count":140,"type":20},144,[23],"Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.",[144,26],"Coronary Microvascular Disease","2023-09-26",{"date":147,"type":31},"2023-09-28",{"date":149,"type":31},"2021-04-01",{"date":151,"type":20},"2029-10-20",{"name":153,"class":68},"Johannes Gutenberg University Mainz",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":181},"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","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","Reducer","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",{"count":163,"type":20},100,[23],"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.",[26],[168,169,54,170],"Neovasc Reducer","Coronary Sinus","angina class 3-4","2022-02-01",{"date":173,"type":31},"2022-02-02",{"date":175,"type":31},"2011-08-30",{"date":177,"type":20},"2031-12-31",{"name":179,"class":180},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",2]