[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stent-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stent-complication":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100528273","phase-1-intra-nasal-ketorolac-for-acute-ureteral-stent-associated-pain-following-ureteroscopy-for-stone-disease-100528273",false,"NCT06158620","Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease","Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease","Inclusion Criteria:\n\n* ≥18 years old\n* English-speaking\n* Candidate for unilateral ureteroscopy for treatment of urolithiasis\n* Surgical plan includes placement of a ureteral stent\n\nExclusion Criteria:\n\n* Pregnant\u002Fnursing, prisoners, cognitively impaired\n* Solitary kidney\n* Stone in transplant kidney\n* Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)\n* History of ureteral reconstruction\n* History of nephrocalcinosis, medullary sponge kidney, cystinuria\n* Immobility or relative immobility\n* Planned staged ureteroscopy\n* History of ureteral stent complication or poor tolerance or a ureteral stent\n* Urinary tract infection or sepsis\n* Current anticoagulation use (81 mg Aspirin permissible)\n* NSAID contraindication (acute renal failure or chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, auto-immune disease)","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents.\n\nSpecific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac.\n\nHypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis.\n\nStudy Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.",[27,28,29,30],"Post Operative Pain","Urolithiasis","Ureter Calculi","Stent Complication","RECRUITING","2026-05-22",{"date":34,"type":35},"2026-05-27","ACTUAL",{"date":37,"type":35},"2025-03-01",{"date":39,"type":20},"2027-12-01",{"name":41,"class":42},"University of Texas Southwestern Medical Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100590549","phase-1-pilot-study-of-the--prototype-nimble-system-feasibility-safety-and-initial-performance-in-non-invasive-detection-of-coronary-in-stent-restenosis-100590549","NCT06968858","Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis","First-in-human Study to Assess the Clinical Feasibility, Safety, and Performance of the α Prototype of the NIMBLE System for Diagnosing Complications in Intracoronary Stents. NIMBLE-I Study.","NIMBLE-I","Inclusion Criteria:\n\n* Prior implantation of one or more coronary stents\n* Clinical symptoms suggestive of stent failure (e.g., chest pain, ischemic ECG changes)\n* Undergoing scheduled coronary angiography\n* Informed consent provided\n\nExclusion Criteria:\n\n* Pregnancy\n* Implanted electronic devices (e.g., pacemakers) that may interfere with MWI\n* Inability to provide consent\n* Chest conditions preventing correct positioning of the device",true,{"count":54,"type":20},30,[23,24],"The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents. The study is being conducted at the Hospital Germans Trias i Pujol in Badalona, Spain, under the supervision of Dr. Oriol Rodríguez Leor, an experienced interventional cardiologist. It is sponsored by NIMBLE Diagnostics, a company developing the NIMBLE system-a non-ionizing, non-invasive prototype based on microwave interferometry (MWI).\n\nThe motivation behind the study stems from the clinical challenge of detecting in-stent restenosis (ISR), a common complication following stent implantation that affects up to 10% of patients. Current diagnostic methods typically rely on invasive procedures such as coronary angiography or intravascular imaging, which are resource-intensive and carry procedural risks. The NIMBLE system has the potential to address this need by providing a safe, fast, and non-invasive alternative capable of detecting structural changes around coronary stents.\n\nThe primary objective of the NIMBLE-I study is to assess the technical feasibility of the NIMBLE device in a real-world clinical setting. Secondary objectives include evaluating the safety of the device, generating preliminary data on its effectiveness by comparing its measurements with those obtained from invasive coronary angiography-the reference standard for diagnosing ISR-and collecting usability data to inform improvements in future versions of the device.\n\nThe study is designed to enroll up to 120 patients of whom 30 will undergo an OCT examination to evaluate the ability of the α prototype to measure ISR. Participants must be adults with previously implanted coronary stents who present with symptoms suggestive of ISR-such as chest pain or ischemic changes on an electrocardiogram-and are already scheduled for diagnostic angiography. Patients with contraindications such as pregnancy, implanted electronic devices (like pacemakers), or anatomical limitations that preclude correct device positioning will be excluded.\n\nThe procedure begins with obtaining informed consent from eligible patients. Prior to the scheduled angiographic procedure, the NIMBLE system is used to perform a non-invasive scan. The device, which includes biocompatible transducers, is placed externally over the patient's chest at the level of the coronary stent. Data acquisition does not interfere with standard clinical care. After the NIMBLE scan, patients proceed with their routine coronary angiography as per standard of care. Importantly, operators performing the angiography remain blinded to the results of the NIMBLE device.\n\nData analysis will focus on two main areas. The primary endpoint is the successful completion of NIMBLE measurements without device-related adverse events. Secondary endpoints include the agreement between NIMBLE output-specifically, a calculated metric called %RIS (percent restenosis intrastent)-and angiographic findings. Statistical methods will be applied to assess sensitivity, specificity, correlation, and agreement between modalities. Usability feedback from clinical operators will also be collected to inform future device iterations.\n\nThe study complies with all applicable regulatory and ethical guidelines, including ISO 14155 and the European Medical Device Regulation (MDR 2017\u002F745). It has been approved by the relevant ethics committee and competent authority before its launch. Each patient's data will be anonymized and handled according to Good Clinical Practice (GCP) standards.\n\nExpected outcomes from the NIMBLE-I study include confirmation that the device can be safely and effectively used in a clinical context and that its diagnostic output correlates with invasive imaging findings. Positive results will lay the groundwork for a pivotal clinical trial and advance the development of a tool that could significantly improve the follow-up of patients with coronary stents. Ultimately, this technology could reduce the need for invasive procedures and enable earlier detection of stent-related complications in an outpatient setting.",[58,59,30],"In-stent Restenosis","Stent Fracture",[61,62,63,64,65],"non-invasive","microwave","prototype","nimble","in-stent restenosis","2025-05-05",{"date":68,"type":35},"2025-05-13",{"date":70,"type":35},"2024-09-12",{"date":72,"type":20},"2025-10",{"name":74,"class":75},"Nimble Diagnostics S.L.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100479379","eluvia-des-for-the-patients-with-femoropopliteal-artery-lesions-100479379","NCT05522218","Eluvia DES for the Patients with Femoropopliteal Artery Lesions.","Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions","Inclusion Criteria:\n\n1. Rutherford Stage 2-5.\n2. At least 90% stenosis or occlusion of the femoropopliteal artery.\n3. Eluvia stents are used for target lesions.\n4. Agree and sign the informed consent form\n\nExclusion Criteria:\n\n1. Life expectancy is less than 1 year.\n2. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.\n3. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.\n4. Patients with in-stent restenosis of the femoral popliteal artery.\n5. Patients with acute arterial thrombosis.",{"count":84,"type":20},400,"OBSERVATIONAL","This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.",[88,30],"Vascular Diseases","2024-09-25",{"date":91,"type":35},"2024-09-27",{"date":93,"type":35},"2022-08-01",{"date":95,"type":20},"2025-12-31",{"name":97,"class":42},"First Affiliated Hospital of Zhejiang University"]