[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuzhou Third People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100605459","the-safety-and-efficacy-of-new-generation-brs-vs-dcb-for-de-novo-large-coronary-artery-lesions-a-prospective-rct-100605459",false,"NCT07162792","The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT","The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study","Inclusion Criteria:\n\n* \\- Radiography inclusion criteria\n\n  1. angiographically confirmed de novo coronary artery lesion;\n  2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n  3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);\n  4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;\n  5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria\n\n  \u003C!-- -->\n\n  1. subjects at the age between ≥18 and ≤80 years old;\n  2. patients with symptoms or evidence of myocardial ischaemia;\n  3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.\n\nExclusion Criteria:\n\n* 1\\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels \\> 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria\n\n  1. Any patient with myocardial infarction within one month;\n  2. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;\n  3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n  4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n  5. Patients with severe renal failure(eGFR\\\u003C30ml\u002Fminute) or such medical history, failure to comply with angiography conditions;\n  6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;\n  7. Patients who plans to accept selective operation within 1 year;\n  8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n  9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.","ALL","18 Years","80 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study plans to enroll 150 patients who are candidates for \"intervention without implantation\" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.",[27,28],"Coronary Artery Disease(CAD)","de Novo Coronary Lesions",[30,31,32],"drug-coated balloon","percutaneous coronary intervention","bioresorbable scaffold","NOT_YET_RECRUITING","2025-09-01",{"date":36,"type":37},"2025-09-09","ACTUAL",{"date":39,"type":21},"2025-10-23",{"date":41,"type":21},"2028-12-30",{"name":43,"class":44},"Xuzhou Third People's Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100567515","intravascular-lithotripsy-for-acute-stent-under-expansion-in-calcified-coronary-lesions-100567515","NCT06669195","Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions","Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions","Inclusion Criteria:\n\n* Radiography inclusion criteria\n\n  1. the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis \\>20% after stenting and 16-atm dilatation with a post-dilatation balloon;\n  2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n  3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);\n\nGeneral inclusion criteria\n\n1. subjects at the age between ≥18 and ≤80 years old;\n2. patients with symptoms or evidence of myocardial ischaemia;\n3. subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.\n\nExclusion Criteria:\n\n* Radiography exclusion criteria\n\n  1. in-stent lesions;\n  2. For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);\n  3. Target lesions were total occlusive lesions (acute or chronic), long lesions (\\>30 mm), lesion vessel reference diameters \\>4.0 mm, and lesion angiomatous dilatation;\n\nGeneral inclusion criteria\n\n1. Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;\n2. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n3. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n4. Patients with severe renal failure(eGFR\\\u003C30ml\u002Fminute) or such medical history, failure to comply with angiography conditions;\n5. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;\n6. Patients who plans to accept selective operation within 1 year;\n7. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n8. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.",{"count":53,"type":21},40,[24],"Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure.\n\nThis study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion\u002Fexclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.",[57,58],"Coronary Artery Disease","Calcification",[60,61,62],"Intravascular lithotripsy","stent under-expansion","calcified coronary lesions","2024-10-31",{"date":65,"type":37},"2024-11-01",{"date":67,"type":21},"2024-12-12",{"date":69,"type":21},"2027-03-13",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100567561","biolimus-coated-balloon-in-de-novo-large-vessel-coronary-lesions-100567561","NCT06669793","Biolimus-Coated Balloon in de Novo Large Vessel Coronary Lesions","A Randomized Trial Comparing the Biolimus-coated Balloon and Paclitaxel-coated Balloon in de Novo Large Vessel Coronary Lesions","Inclusion Criteria:\n\n* Radiography inclusion criteria\n\n  1. angiographically confirmed de novo coronary artery lesion;\n  2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n  3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);\n  4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;\n  5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria\n\n  \u003C!-- -->\n\n  1. subjects at the age between ≥18 and ≤80 years old;\n  2. patients with symptoms or evidence of myocardial ischaemia;\n  3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation and at 30 days, 6 months, 9 months and 12 months after operation.\n\nExclusion Criteria:\n\n* Radiography exclusion criteria\n\n  1. in-stent lesions;\n  2. For the left main disease, true bifurcation lesion, chronic total occlusive lesions;\n  3. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation;\n  4. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria\n\n  \u003C!-- -->\n\n  1. Any patient with myocardial infarction within one month;\n  2. Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;\n  3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n  4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n  5. Patients with severe renal failure(eGFR\\\u003C30ml\u002Fminute) or such medical history, failure to comply with angiography conditions;\n  6. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;\n  7. Patients who plans to accept selective operation within 1 year;\n  8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n  9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.",{"count":79,"type":21},475,[24],"Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation.\n\nThis study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI.\n\nThey are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.",[83],"Coronary Arterial Disease (CAD)",[85,86,87,88],"paclitaxel-coated balloon","biolimus-coated balloon","de novo lesions","large coronary artery vessel","2024-10-30",{"date":65,"type":37},{"date":92,"type":21},"2024-12-10",{"date":94,"type":21},"2028-05-23",{"name":43,"class":44},""]