[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sahajanand Medical Technologies Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,64,85,104],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100567093","cruz-tunisia-multivessel-registry-100567093",false,"NCT06663696","CRUZ Tunisia-Multivessel Registry","Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease","Inclusion Criteria:\n\n1. Patient must be at least 18 years of age\n2. Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure\n3. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his\u002Fher medical information by signing a Patient Informed Consent Form\n4. The patient is willing and able to co-operate with study procedures and required follow up visits\n\nExclusion Criteria:\n\n1. Women with known pregnancy or who are lactating\n2. High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)\n3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements\n4. Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation \u002F antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media","ALL","18 Years","99 Years",{"count":20,"type":21},1000,"ESTIMATED","12 Months","OBSERVATIONAL","The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).",[26],"Patient Population With Multivessel Disease",[28],"Multivessel disease, Supraflex Cruz, SES","RECRUITING","2026-04-22",{"date":32,"type":33},"2026-04-27","ACTUAL",{"date":35,"type":33},"2024-11-01",{"date":37,"type":21},"2028-05",{"name":39,"class":40},"Sahajanand Medical Technologies Limited","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":51,"studyType":23,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100555091","hydra-registry---uk-100555091","NCT06507579","Hydra Registry - UK","Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation\n2. Full understanding and willing to provide informed consent to study enrolment\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.",{"count":50,"type":21},250,"1 Year","The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.\n\nThe study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.",[54],"Aortic Valve Stenosis",[56],"Aortic Valve Stenosis, TAVI, Hydra",{"date":32,"type":33},{"date":59,"type":33},"2024-07-11",{"date":61,"type":21},"2026-08-01",{"name":39,"class":40},4,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":51,"studyType":23,"phases":4,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100542420","hydra-single-centre-experience---copenhagen-denmark-100542420","NCT06342635","Hydra Single-centre Experience - Copenhagen, Denmark","Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation\n3. Full understanding and willing to provide informed consent to study enrolment\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator",{"count":72,"type":21},50,"The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.",[54],[54,76,77],"TAVI","Hydra",{"date":32,"type":33},{"date":80,"type":33},"2024-06-18",{"date":82,"type":21},"2027-10-31",{"name":39,"class":40},1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":92,"targetDuration":94,"studyType":23,"phases":4,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":63},"100512761","hydra-registry---italy-experience-100512761","NCT05956652","Hydra Registry - Italy Experience","Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis","Inclusion Criteria:\n\n* Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team\n* Ability to understand and provide informed consent for inclusion in the study\n\nExclusion Criteria:\n\n* Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.\n* Refusal by the patient to participate in the study\n* High probability of non-adherence to required follow-ups",{"count":93,"type":21},500,"5 Years","Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.",[54],[54,76,77],{"date":32,"type":33},{"date":100,"type":33},"2023-07-01",{"date":102,"type":21},"2029-07-31",{"name":39,"class":40},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100319839","s-flex-netherlands-registry-prospective-evaluation-of-the-supraflex-family-sirolimus-eluting-coronary-stent-system-100319839","NCT03443999","S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System","Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his\u002Fher medical information by signing a Patient Informed Consent Form\n3. Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.\n4. The patient is willing and able to cooperate with study procedures and required follow up visits\n\nExclusion Criteria:\n\n1. Women with known pregnancy or who are lactating\n2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)\n3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements\n4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period",{"count":112,"type":21},10000,"The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.",[115],"Coronary Artery Disease",[115,117,118],"Sirolimus-eluting Stent","Biodegradable Polymers",{"date":120,"type":33},"2026-04-23",{"date":122,"type":33},"2018-02-27",{"date":124,"type":21},"2027-12",{"name":39,"class":40},7,""]