[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lepu Medical Technology (Beijing) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100596925","to-evaluate-the-safety-and-efficacy-of-a-single-use-ivus-ablation-for-primary-hypertension-100596925",false,"NCT07051811","To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension","A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤75 years, regardless of gender.\n2. Documented history of primary hypertension.\n3. Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB\u002FCCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:\n\n   1. Office systolic blood pressure (SBP) ≥150 mmHg and \\\u003C180 mmHg;\n   2. Office diastolic blood pressure (DBP) ≥90 mmHg;\n   3. 24-hour ambulatory systolic blood pressure ≥135 mmHg and \\\u003C170 mmHg.\n4. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.\n\nExclusion Criteria:\n\n1. Unsuitable Renal Artery Anatomy for Treatment\n\n   1. Main renal artery diameter \\\u003C4 mm or length \\\u003C20 mm.\n   2. Accessory renal artery diameter ≥ 2 mm and \\\u003C4 mm.\n   3. Renal artery stenosis \\>50% in the main renal artery.\n   4. Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.\n   5. Presence of a renal artery stent.\n   6. Single kidney.\n2. Estimated Glomerular Filtration Rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m².\n3. Diagnosis of Type 1 Diabetes Mellitus.\n4. Orthostatic Hypotension.\n5. Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.\n6. Suspected Secondary Hypertension.\n7. Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).\n8. Prior Renal Artery Denervation Procedure.\n9. Life Expectancy \\\u003C1 Year.\n10. Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.\n11. Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.\n12. Allergy to Contrast Agents.\n13. Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).","ALL","18 Years","75 Years",{"count":20,"type":21},213,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.",[27],"Essential Hypertension","RECRUITING","2025-07-02",{"date":31,"type":32},"2025-07-04","ACTUAL",{"date":34,"type":32},"2025-02-25",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"Lepu Medical Technology (Beijing) Co., Ltd.","INDUSTRY",18,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100438889","optimized-antiplatelet-therapy-in-patients-with-chd-after-implantation-of-neovas-brs-system-100438889","NCT04995159","Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System","Evaluate the Safety and Efficacy of Optimized Antiplatelet Therapy in Patients With Coronary Heart Disease After Implantation of NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System.","Inclusion Criteria:\n\n* Age 18 or above, male or non-pregnant female.\n* Evidence of myocardial ischemia (e.g., stable angina, unstable angina, medium-low risk NSTEMI, STEMI with onset more than 1 week, old myocardial infarction or asymptomatic myocardial ischemia), and suitable for PCI surgery.\n* The target lesion is in-situ coronary artery lesion, the total length of single lesion is no more than 40mm (the total length of stent is no more than 48mm), and the diameter of the target lesion is between 2.75mm and 3.75mm (visual measurement).\n* The diameter stenosis of target lesion is ≥70% in visual (or ≥50% with clinical evidence of myocardial ischemia in that range), and the TIMI blood flow is greater than grade 1.\n* The stent with diameter more than 3.0mm is allowed to overlap with another stent once, the overlapping methods could be edge to edge or at most 1mm overlap. The total number of stents per patient is no more than 4, with a maximum of 2 stents per vessel (the 2.75mm diameter stent is not allowed to overlap).\n* Patient with indications for coronary artery bypass surgery.\n* Aspirin and clopidogrel could be used continuously during the study.\n* Patient who can understand the purpose of this trial, is willing to participate in the trial and to conduct clinical follow-up as required by the study protocol.\n\nExclusion Criteria:\n\n* Acute ST-segment elevation myocardial infarction within 1 week.\n* Left main coronary artery disease, branch vessel diameter≥2.0mm, three-vessel coronary artery disease and bridge vessel disease; visible thrombus in the target vessel.\n* Severe distortion, severe calcification that cannot be successfully predilated, and other lesions that are not suitable for stent delivery and deployment.\n* Intra-stent restenosis.\n* Severe heart failure (NYHA≥III or left ventricular ejection fraction\\\u003C35%).\n* Severe renal insufficiency, eGFR\\\u003C30ml\u002Fmin\u002F1.73m2 or serum creatinine\\>2.5mg\u002FdL (221μmol\u002FL).\n* Patients with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half a year, fundus hemorrhage affecting vision, antiplatelet agents and anticoagulant treatment contraindications who cannot receive antithrombotic therapy.\n* Patients requiring long-term oral anticoagulants during the study period.\n* Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n* Patients with malignancies, organ transplants, or drug addiction that can seriously affect study compliance.\n* Patients with contraindications to aspirin, clopidogrel or ticagrelor.\n* Known allergy to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, polylactic acid polymer and rapamycin.\n* Thrombosis occurred during previous clopidogrel treatment.\n* Life expectancy is less than 36 months.\n* Participated in clinical trials of other drugs or medical devices before enrollment and failed to meet the time limit of the primary end point.\n* Patients who will have elective surgery within a year and need to discontinue aspirin, clopidogrel or ticagrelor.\n* Subjects are deemed unsuitable for enrollment by investigators.",{"count":49,"type":21},2150,[24],"This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.",[53],"Coronary Heart Disease",[55,56,53,57],"Bioabsorbable Coronary Artery Rapamycin-eluting Stent System","Optimized Antiplatelet Therapy","Randomized Controlled Trial","NOT_YET_RECRUITING","2021-07-29",{"date":61,"type":32},"2021-08-06",{"date":63,"type":21},"2021-09",{"date":65,"type":21},"2028-01",{"name":38,"class":39},114,""]