[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai MicroPort Rhythm MedTech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100053574","coronary-laser-atherectomy-system-for-treatment-of-coronary-artery-stenosis-shine-100053574",false,"NCT07697638","Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)","A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Laser Atherectomy System in Patients With Coronary Artery Stenosis (SHINE)","SHINE","Inclusion Criteria:\n\nClinical Inclusion Criteria:\n\n1. Age 18-85 years, male or female.\n2. Coronary angiography confirms the need for PCI.\n3. Diagnosed with stable angina, silent myocardial ischemia, unstable angina, non-ST-segment elevation myocardial infarction, or STEMI \\>7 days.\n4. During PCI, the investigator determines that laser atherectomy is required for lesion pretreatment.\n5. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent form acknowledging the risks and benefits described in the informed consent document, and able to complete clinical follow-up as required.\n\nAngiographic Inclusion Criteria (visual estimate):\n\n1. Target lesion reference vessel diameter (RVD) ≥2.00 mm by visual estimate.\n2. Target lesion stenosis ≥70% (visual estimate), or ≥50% and \\\u003C70% with evidence of ischemia. Evidence of ischemia includes any of the following:\n\n   * Positive exercise stress test\n   * FFR or QFR ≤0.8\n   * Meets severe stenosis criteria by intracoronary imaging (IVUS or OCT): MLA \\\u003C2.4 mm² for vessels with diameter \\\u003C3.0 mm; MLA \\\u003C2.7 mm² for vessels with diameter 3.0-3.5 mm; MLA \\\u003C3.6 mm² for vessels with diameter \\>3.5 mm\n3. Target lesion is a small-diameter predilation balloon (balloon diameter ≤1.5 mm), uncrossable and\u002For undilatable lesion (undilatable under stent post-dilation balloon rated burst pressure and\u002For special circumstances unsuitable for dilation), including calcified lesions, CTO lesions, in-stent restenosis, stent underexpansion, and high thrombus burden lesions.\n4. Guidewire successfully passes through the true lumen of the target lesion without NHLBI type C or higher dissection.\n\nExclusion Criteria:\n\nClinical Exclusion Criteria:\n\n1. Hemodynamic instability or severely reduced exercise tolerance (NYHA Class III or IV).\n2. Severe heart failure with reduced ejection fraction (LVEF \\\u003C30%).\n3. Intracardiac thrombus on echocardiography within 30 days prior to enrollment.\n4. Has received an organ transplant or is awaiting an organ transplant.\n5. Currently receiving chemotherapy or scheduled to receive chemotherapy within 30 days before or after the baseline procedure.\n6. Has a bleeding diathesis, contraindication to antiplatelet or anticoagulant therapy, or is unable to receive antithrombotic therapy.\n7. Chronic renal insufficiency with serum creatinine \\>2.5 mg\u002FdL (or 221 µmol\u002FL).\n8. Cerebrovascular accident (CVA), transient ischemic attack (TIA), or permanent neurological deficit that may preclude compliance with the protocol within the past 6 months.\n9. Unconscious or requiring circulatory support or mechanical ventilation before PCI.\n10. The target vessel (including side branches) has received any PCI within 1 month prior to the baseline procedure.\n11. Planned interventional or cardiac surgical procedure within 30 days after baseline procedure.\n12. Prior coronary intravascular brachytherapy at any time.\n13. Allergy to medications or devices required during PCI (including but not limited to rapamycin, paclitaxel, dual antiplatelet agents, polyamide, polyurethane, PTFE, or stainless steel).\n14. Other severe medical conditions (e.g., cancer, congestive heart failure) with life expectancy \\\u003C12 months.\n15. Current substance abuse or addiction (e.g., alcohol, cocaine, heroin).\n16. Currently participating in another investigational drug or device trial that has not reached its primary endpoint, or planning to participate in another investigational drug or device trial within 6 months after the baseline procedure.\n17. Plans to conceive within 6 months after baseline procedure.\n18. Pregnant or breastfeeding women (pregnancy test required within 7 days before baseline procedure for women of childbearing potential).\n19. The investigator determines that the subject is unsuitable for enrollment.\n\nAngiographic Exclusion Criteria (visual estimate):\n\n1. Target lesion meets any of the following criteria:\n\n   -≥2 target lesions requiring treatment during the baseline procedure\n   * Ostial lesion (within 3 mm of the ostium)\n   * Medina type \"x, x, 1\" bifurcation lesion\n   * Intimal dissection (NHLBI type C or higher)\n   * Guidewire-uncrossable total occlusion\n   * Severely angulated lesion\n2. Unprotected left main coronary artery disease (\\>50% diameter stenosis).\n3. The target vessel has other clinically significant lesions that may require intervention within 6 months after the baseline procedure.\n4. Predicted inability to deliver the laser fiber catheter to the target lesion due to various reasons (e.g., severe proximal tortuosity of the target vessel).","ALL","18 Years","85 Years",{"count":21,"type":22},218,"ESTIMATED","INTERVENTIONAL",[25],"NA","This prospective, multi-center clinical trial evaluates the safety and efficacy of the Coronary Laser Atherectomy System for the pretreatment of coronary artery stenosis. The study consists of two phases: a first-in-human (FIM) phase enrolling 5 subjects in a single center, and a pivotal phase, which is a prospective, multi-center, randomized controlled, non-inferiority trial enrolling 218 subjects across approximately 10 centers in China. Subjects are randomized 1:1 to receive either the investigational laser system or the control Philips CVX300 laser system for lesion pretreatment prior to PCI. The primary endpoint is clinical success, defined as successful PCI with residual stenosis \\\u003C30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization through 7 days post-procedure. Secondary endpoints include device success, procedural success, MACE, target lesion failure, and target vessel failure at 30 days and 6 months. An OCT sub-study is planned for 40 subjects.",[28],"Coronary Artery Stenosis","NOT_YET_RECRUITING","2026-07-05",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-11-10",{"date":37,"type":22},"2027-12-03",{"name":39,"class":40},"Shanghai MicroPort Rhythm MedTech Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100620162","the-coronary-sinus-balloon-pump-in-stemi-100620162","NCT07354035","The Coronary Sinus Balloon Pump in STEMI","A Prospective, Randomized, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Use of Coronary Sinus Balloon Pump Along With PCI in STEMI Patients","REVIVE-RCT","Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n1. Subjects aged ≥18 and ≤80 years, clinically diagnosed with ST-segment elevation myocardial infarction (STEMI).\n2. Left ventricular ejection fraction (LVEF) ≤50% and ≥35% as assessed by echocardiography or left ventriculography prior to PCI.\n3. Symptoms of myocardial infarction (e.g., persistent chest pain, with or without shortness of breath, nausea\u002Fvomiting, profuse sweating, dyspnea, syncope) consistent with the timing of myocardial ischemia, with symptom onset within 24 hours.\n4. Electrocardiographic evidence of acute anterior wall myocardial infarction, defined as ST-segment elevation ≥1 mm (0.1 mV) in at least two contiguous precordial leads on a 12-lead ECG. For leads V2 or V3, the following gender- and age-specific cutoffs apply:\n\n   * 2 mm (0.2 mV) in men ≥45 years old.\n   * 2.5 mm (0.25 mV) in men \\\u003C40 years old.\n   * 1.5 mm (0.15 mV) in women.\n5. Subject is eligible for primary percutaneous coronary intervention (primary PCI).\n6. Subject is able to understand the purpose of the study, voluntarily agrees to participate by signing the informed consent form acknowledging the risks and benefits described therein, and is willing and able to comply with the required clinical follow-up procedures.\n\nAngiographic Inclusion Criteria:\n\n1. The target lesion is located in the proximal or mid segment of the left anterior descending artery (LAD).\n2. TIMI flow grade of the target vessel is 0, 1, or 2 prior to PCI treatment.\n\nExclusion Criteria:\n\n1. Presence of an implant or foreign body within the coronary sinus.\n2. The target lesion involves the left main coronary artery, or there is a ≥50% stenosis in the left main coronary artery.\n3. Known allergy or contraindication to drugs or materials required during PCI and the use of the investigational device (including, but not limited to, sirolimus, dual antiplatelet therapy drugs, polyamide, polyurethane, polytetrafluoroethylene, or stainless steel).\n4. Presence of pericardial effusion (moderate or greater), cardiac tamponade, hemodynamically significant left\u002Fright shunt, or severe valvular heart disease.\n5. Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.\n6. History of acute myocardial infarction, or documented history of hospitalization for Q-wave infarction.\n7. History of cerebral infarction, intracerebral hemorrhage, transient ischemic attack (TIA), or reversible ischemic neurologic deficit within the past 6 months, or presence of permanent neurological deficit.\n8. Known hemoglobin level below 90 g\u002FL, platelet count below 80×10⁹\u002FL, history of bleeding diathesis or coagulation disorder, or unwillingness to receive blood transfusion.\n9. Subjects requiring circulatory support or assisted ventilation.\n10. Subjects experiencing cardiac arrest or cardiopulmonary resuscitation (CPR) for more than 5 minutes preoperatively (baseline) or intraoperatively.\n11. Subjects unsuitable for femoral or jugular venous access.\n12. Known contraindications to cardiac magnetic resonance imaging (CMR), such as claustrophobia, presence of non-CMR compatible foreign bodies or implants, or allergy\u002Fintolerance to gadolinium-based contrast agents.\n13. Prior coronary artery bypass graft (CABG) surgery.\n14. Visible well-developed collateral circulation distal to the target lesion in the target vessel.\n15. Current participation in another clinical drug or device study where the primary endpoint has not been reached, or planned participation in another investigational drug or device clinical trial within 12 months after the baseline procedure.\n16. Known severe renal disease (estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002F(min·1.73m²) as calculated by the MDRD formula\\*) or undergoing hemodialysis.\n17. History of treatment for malignancy within the past 12 months.\n18. Subjects with chronic obstructive pulmonary disease (COPD) who are on home oxygen therapy or receiving chronic steroid therapy.\n19. Impaired consciousness during PCI, cardiogenic shock (persistent systolic blood pressure ≤90 mmHg despite conservative treatment), or pulmonary edema (peripheral oxygen saturation \\\u003C90% with rales).\n20. Any vascular PCI treatment received within 1 week prior to enrollment.\n21. Fibrinolytic therapy received within 24 hours prior to enrollment.\n22. -target lesions in vessels other than the left anterior descending artery and its branches requiring treatment during this PCI or within one week thereafter.\n23. Known pregnancy or breastfeeding, or female subjects planning pregnancy within 1 year post-procedure and unable to complete follow-up as required.\n24. Subjects judged by the investigator to have poor compliance and unable to complete the study as required, or any other reason the investigator deems the subject unsuitable for enrollment.","80 Years",{"count":51,"type":22},177,[25],"This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of the coronary sinus balloon pump (manufactured by Shanghai MicroPort Rotapace Medical Technology Co., Ltd.) as an adjunctive therapy during percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). As a pivotal study, it aims to support the product registration application to the National Medical Products Administration (NMPA).",[55],"STEMI","2026-01-20",{"date":58,"type":33},"2026-01-21",{"date":60,"type":22},"2026-02-12",{"date":62,"type":22},"2026-06",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100599258","the-first-in-man-use-of-coronary-sinus-balloon-pump-in-stemi-patients-treated-by-primary-pci-100599258","NCT07082153","The First-In-Man Use of Coronary Sinus Balloon Pump in STEMI Patients Treated by Primary PCI","A Prospective, Multicenter Clinical trIal in Evaluating the Safety and Efficacy of the Coronary Sinus Balloon Pump for the First-In-Man Use in STEMI Patients","REVIVE-FIM","Inclusion Criteria:\n\nClinical inclusion criteria：\n\n1. Subjects aged ≥18 and ≤80 years with clinically confirmed ST-segment elevation myocardial infarction (STEMI).\n2. Left Ventricular Dysfunction: Left ventricular ejection fraction (LVEF) ≤50% assessed by pre-PCI echocardiography or left ventriculography.\n3. Ischemic Symptoms: Presence of myocardial infarction symptoms consistent with ischemic timing (e.g., persistent chest pain, with or without dyspnea, nausea\u002Fvomiting, diaphoresis, syncope), with symptom onset between 6 and 24 hours prior to enrollment.\n4. Electrocardiographic Evidence:\n\n   * Acute anterior wall myocardial infarction confirmed by 12-lead ECG, demonstrating ST-segment elevation ≥1 mm (0.1 mV) in ≥2 contiguous precordial leads.\n   * For leads V2 or V3:\n\n   Men: ST-segment elevation ≥2 mm (0.2 mV) Women: ST-segment elevation ≥1.5 mm (0.15 mV).\n5. PCI Eligibility: Candidate for primary percutaneous coronary intervention (PCI).\n6. Subjects who can understand the purpose of the trial, voluntarily participate and acknowledge the risks and benefits described in the informed consent document by signing the informed consent form, and can conscientiously complete clinical follow-up as required\n\nAngiography Inclusion Criteria:\n\n1. Target Lesion Location: Located in the proximal or mid segment of the Left Anterior Descending artery (LAD).\n2. Pre-PCI TIMI Flow: TIMI flow grade 0 or 1 in the target vessel prior to percutaneous coronary intervention (PCI).\n\nExclusion Criteria:\n\n1. Presence of implants or foreign bodies within the coronary sinus.\n2. Target lesion involving the left main coronary artery or ≥50% stenosis in the left main coronary artery.\n3. Known hypersensitivity to medications or devices required during PCI or the investigational device (including but not limited to: rapamycin, polyurethane in dual antiplatelet therapy, PET, or stainless steel).\n4. Pericardial effusion (moderate or larger volume), cardiac tamponade, hemodynamically significant left\u002Fright shunts, or severe valvular heart disease.\n5. Intracardiac thrombus detected by echocardiography within 30 days prior to enrollment.\n6. History of acute myocardial infarction (AMI) or documented hospitalization for Q-wave infarction.\n7. History of cerebral infarction, intracranial hemorrhage, transient ischemic attack (TIA), or reversible ischemic neurologic deficit within the past 6 months, or permanent neurological deficits.\n8. Hemoglobin \\\u003C90 g\u002FL, platelet count \\\u003C80×10⁹\u002FL, history of bleeding disorders\u002Fcoagulopathy, or refusal to accept blood transfusion.\n9. Requiring circulatory support or assisted ventilation therapy.\n10. Cardiac arrest or cardiopulmonary resuscitation (CPR) \\>5 minutes during pre-procedural baseline or intra-procedural period.\n11. Unsuitable femoral or jugular venous access.\n12. Contraindications to cardiac magnetic resonance imaging (CMR), including claustrophobia, CMR-incompatible implants\u002Fforeign bodies, or gadolinium contrast allergy\u002Fintolerance.\n13. Prior coronary artery bypass grafting (CABG).\n14. Visible collateral circulation formation distal to the target lesion in the target vessel.\n15. Current participation in another investigational drug\u002Fdevice trial (prior to primary endpoint completion) or planned enrollment in another trial within 12 months post-procedure.\n16. Severe renal dysfunction (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² by MDRD equation\\*) or ongoing hemodialysis.\n17. Active malignancy treatment within the past 12 months.\n18. Chronic obstructive pulmonary disease (COPD) requiring home oxygen therapy or chronic steroid therapy.\n19. Impaired consciousness during PCI, cardiogenic shock (persistent SBP ≤90 mmHg despite conservative therapy), or pulmonary edema (peripheral SpO₂ \\\u003C90% with rales).\n20. Any vascular PCI performed within 7 days prior to hospitalization.\n21. Fibrinolytic therapy administered within 24 hours prior to hospitalization.\n22. Non-target lesions requiring treatment during index PCI or within 1 week post-procedure (excluding LAD and its branches).\n23. Pregnancy, lactation, or female subjects planning pregnancy within 1 year post-procedure unable to complete follow-up.\n24. Poor protocol compliance per investigator's judgment, or subjects deemed ineligible due to other reasons.",{"count":73,"type":22},10,[25],"This is a prospective, multicenter clinical investigation aiming to evaluate the safety and efficacy of the coronary sinus balloon pump in its first application in patients with acute ST-segment elevation myocardial infarction (STEMI).",[55],[55,78],"the coronary sinus balloon pump","2025-07-21",{"date":81,"type":33},"2025-07-24",{"date":83,"type":22},"2025-08-12",{"date":85,"type":22},"2026-03-03",{"name":39,"class":40},""]