[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"critical-limb-threatening-ischaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:critical-limb-threatening-ischaemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100651640","dcb-outcomes-after-non-compliant-balloon-vessel-preparation-with-or-without-scoring-in-patients-with-femoropopliteal-arterial-disease-100651640",false,"NCT07764016","DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease","Drug-coated Balloon Angioplasty After Non-Compliant Balloon Vessel Preparation With or Without Scoring for Femoropopliteal Arterial Disease: A Randomized Controlled Trial","DASBAD-NC","Inclusion Criteria:\n\n* ≥18 years of age.\n* Rutherford class 4-5.\n* Estimated life expectancy \\>1 year, per investigator's judgment.\n* Significant atherosclerotic lesions (≥50% stenosis or chronic total occlusion) in the femoropopliteal segment, including in-stent restenosis.\n* Signed informed consent.\n* Willingness to comply with follow-up visits.\n* ≥1 patent infragenicular artery (\\\u003C50% stenosis) at the end of the procedure.\n* Target vessel diameter ≤8 mm.\n\nExclusion Criteria:\n\n* Pregnant or planning pregnancy during the study.\n* Participation in another drug\u002Fdevice trial.\n* Inability to cross the target lesion with a guidewire. Successful crossing is defined as advancement of the guidewire tip distal to the target lesion without vessel perforation or flow-limiting dissection.\n* Inadequate treatment of proximal lesion (\\>30% residual stenosis).\n* Severe calcification of the target vessel \\[group 4 of Fanelli classification17 defined as circumferential calcification (270º-360º)\\], evidenced before contrast injection or digital subtraction angiography.\n* Thrombus in the target vessel.\n* Anastomotic stenosis of a bypass.\n* Use of atherectomy, thrombectomy, laser, or similar devices.\n* Prior or planned above-the-ankle amputation of the target limb.\n* Coagulopathy, hypercoagulable state, bleeding diathesis, platelets \\\u003C80 000\u002FµL or \\>700 000\u002FµL, or other blood disorder.\n* Gastrointestinal bleeding requiring transfusion within 3 months.\n* Contraindication to antiplatelet\u002Fanticoagulant\u002Fthrombolytic therapy.\n* Acute coronary syndrome within 30 days.\n* Stroke or TIA within 90 days.\n* Hypersensitivity\u002Fcontraindication to nitinol.\n* Comorbidities precluding treatment or follow-up (per investigator).\n* Hypersensitivity\u002Fallergy to contrast not manageable medically.\n* Hypersensitivity\u002Fallergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet\u002Fanticoagulant agents.\n* Contraindication to dual antiplatelet therapy.","ALL","18 Years",{"count":20,"type":21},142,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel preparation using a non-compliant plain balloon in patients with chronic limb-threatening ischaemia (CLTI) undergoing femoropopliteal endovascular intervention.\n\nThe main questions the study aims to answer are:\n\n* Does non-compliant scoring balloon vessel preparation reduce the need for bailout stenting during the index procedure?\n* Does it improve primary patency after DCB angioplasty?\n* Does it improve clinically relevant outcomes such as wound healing, freedom from clinically driven target lesion revascularisation, limb salvage and health-related quality of life?\n* Does it provide procedural and economic advantages compared with non-compliant plain balloon vessel preparation?\n\nParticipants will be randomly assigned to undergo vessel preparation using either a non-compliant plain balloon or the DKutting™ non-compliant scoring balloon, followed by angioplasty with the Legflow XP™ drug-coated balloon. Patients will undergo clinical, duplex ultrasound and quality-of-life follow-up for 24 months.",[27,28,29,30],"Femoropopliteal Disease","Drug Coated Balloon","Critical Limb-Threatening Ischaemia","Peripheral Arterial Disease",[32,33,27,34,35,36,37,38,39],"Chronic Limb-Threatening Ischaemia (CLTI)","Peripheral Artery Disease (PAD)","Drug-Coated Balloon (DCB)","Vessel Preparation","Scoring Balloon","Non-Compliant Balloon","Primary Patency","Bailout Stenting","NOT_YET_RECRUITING","2026-08-12",{"date":43,"type":44},"2026-08-14","ACTUAL",{"date":46,"type":21},"2026-12",{"date":48,"type":21},"2030-12",{"name":50,"class":51},"Marc Sirvent","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":83},"100633684","symptoms-of-anxiety-andor-depression-and-sdm-in-older-patients-with-clti-100633684","NCT07529886","Symptoms of Anxiety and\u002For Depression and SDM in Older Patients With CLTI","Symptoms of Anxiety and\u002For Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)","Inclusion Criteria:\n\n* Patients\n\n  * Aged ≥65 years old\n  * CLTI\n  * Active symptoms of anxiety or depression (clinician concern)\n* Carers\n\n  o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression\n* Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI\n\nExclusion Criteria:\n\n* Patients\n\n  * Palliative - death anticipated within one month\n  * Clinical and research team identify as lacking capacity to participate\n* Carers\n\n  o Clinical and research team identify as lacking capacity to participate\n* Staff o Not providing care for older people with CLTI",true,"65 Years",{"count":62,"type":21},30,"OBSERVATIONAL","Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes.\n\nSurgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life.\n\nShared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.",[66,67,68],"Critical Limb Threatening Ischaemia","Depression Disorder","Anxiety",[70,71,72,73,74],"Shared decision making","Perioperative medicine","Geriatrics","Mental health problems","Vascular surgery","2026-04-14",{"date":77,"type":44},"2026-04-17",{"date":79,"type":21},"2026-06",{"date":46,"type":21},{"name":82,"class":51},"Guy's and St Thomas' NHS Foundation Trust",1]