Nctid:
NCT06234280
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000058729", "term"=>"Peripheral Arterial Disease"}, {"id"=>"D000089802", "term"=>"Chronic Limb-Threatening Ischemia"}], "ancestors"=>[{"id"=>"D000007511", "term"=>"Ischemia"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000050197", "term"=>"Atherosclerosis"}, {"id"=>"D000001161", "term"=>"Arteriosclerosis"}, {"id"=>"D000001157", "term"=>"Arterial Occlusive Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000016491", "term"=>"Peripheral Vascular Diseases"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M29213", "name"=>"Peripheral Arterial Disease", "asFound"=>"Peripheral Artery Disease", "relevance"=>"HIGH"}, {"id"=>"M10418", "name"=>"Intermittent Claudication", "relevance"=>"LOW"}, {"id"=>"M2714", "name"=>"Chronic Limb-Threatening Ischemia", "asFound"=>"Critical Limb Ischemia", "relevance"=>"HIGH"}, {"id"=>"M18894", "name"=>"Peripheral Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M26188", "name"=>"Atherosclerosis", "relevance"=>"LOW"}, {"id"=>"M4469", "name"=>"Arteriosclerosis", "relevance"=>"LOW"}, {"id"=>"M4465", "name"=>"Arterial Occlusive Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>100}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2018-05-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-12-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-06-07", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Clinical patency", "timeFrame"=>"at 24 months", "description"=>"Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or \\> 50% restenosis on imaging studies at 24 months."}], "secondaryOutcomes"=>[{"measure"=>"Ankle-brachial index", "timeFrame"=>"at 12 and 24 months", "description"=>"Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm"}, {"measure"=>"Ruthford category", "timeFrame"=>"at 12 and 24 months", "description"=>"Rutherford category - symptom status by Rutherford category"}, {"measure"=>"target lesion revascularization", "timeFrame"=>"at 12 and 24 months", "description"=>"Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (\\>50% stenosis) in the target lesion"}, {"measure"=>"stent fracture rate", "timeFrame"=>"at 12 and 24 months", "description"=>"stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Peripheral artery disease", "femoropopliteal", "drug-eluting stent", "restenosis"], "conditions"=>["Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions", "Moderate or Severe Claudication (Rutherford Category 2 or 3)", "Critical Limb Ischemia (Rutherford Category 4 or 5)"]}, "descriptionModule"=>{"briefSummary"=>"* Prospective, multi-center single-arm observational study\n* A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.\n* Patients will be followed clinically for 24 months after the procedure.\n* An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months.\n* Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.", "detailedDescription"=>"• Prospective, multi-center single-arm observational study\n\nScreening (day 0):\n\n1. Medical history and demography of the patient reviewed\n2. Inclusion/exclusion eligibility will be checked\n3. Physical examination (Height, weight)\n4. Laboratory test\n\n * BUN, eGFR, Cr.\n * Hb, WBC, platelet\n * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)\n5. Ankle-brachial index\n6. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)\n7. Medication\n\nEnrollment (day 0):\n\n1) Written consent\n\nPost PTA (Day 1 \\~3):\n\n1. Adverse event\n2. Ankle-brachial index\n3. Laboratory test:\n\n * BUN, eGFR, Cr.\n * Hb, WBC, platelet\n4. Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days)\n\n1) Symptom: Rutherford class 2) Laboratory test:\n\n* BUN, eGFR, Cr.\n* Hb, WBC, platelet 3) Concomitant medication 4) Adverse event Visit 2 (post-PTA 6 months ± 30 days)\n\n 1. Symptoms: Rutherford class\n 2. Ankle-brachial index\n 3. Concomitant medication\n 4. Adverse event Visit 3 (post-PTA 12 months ± 60 days)\n\n <!-- -->\n\n 1. Symptoms: Rutherford class\n 2. Ankle-brachial index\n 3. Duplex ultrasound, CT, or catheter angiography\n 4. Biplane radiograph of femur for evaluation of stent fracture\n 5. Laboratory test\n* BUN, eGFR, Cr.\n* Hb, WBC, platelet\n* Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 6)Concomitant medication 7) Adverse event Visit4 (post-PTA 24 months ± 60 days)\n\n 1. Symptom: Rutherford category\n 2. Adverse events"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"19 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Symptomatic peripheral artery disease with femoropopliteal lesions:\n\n* Moderate or severe claudication (Rutherford category 2 or 3)\n* Critical limb ischemia (Rutherford category 4 or 5) Age: ≥19 years, but not older than 85 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age 19 years of older\n2. Symptomatic peripheral artery disease:\n\n * Moderate or severe claudication (Rutherford category 2 or 3)\n * Critical limb ischemia (Rutherford category 4-5)\n3. Femoropopliteal artery lesions with stenosis \\> 50%\n4. ABI \\< 0.9 before treatment\n5. Patents treated with ELUVIA stent for femoropopliteal artery disease\n6. Patients with signed informed consent\n\nExclusion Criteria:\n\n1. Acute critical limb ischemia\n2. Severe critical limb ischemia (Rutherford category 6)\n3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents\n4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)\n5. Bypass graft lesions\n6. Age \\> 85 years\n7. Severe hepatic dysfunction (\\> 3 times normal reference values)\n8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis\n9. LVEF \\< 40% or clinically overt congestive heart failure\n10. Pregnant women or women with potential childbearing\n11. Life expectancy \\<1 year due to comorbidity\n12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)"}, "identificationModule"=>{"nctId"=>"NCT06234280", "acronym"=>"K-ELUVIA", "briefTitle"=>"Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "officialTitle"=>"Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease", "orgStudyIdInfo"=>{"id"=>"1-2017-0095"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Eluvia", "description"=>"Patients treated with Eluvia stent", "interventionNames"=>["Device: Implantation of Eluvia stent"]}], "interventions"=>[{"name"=>"Implantation of Eluvia stent", "type"=>"DEVICE", "description"=>"Implantation of Eluvia stent", "armGroupLabels"=>["Eluvia"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seoul", "country"=>"Korea, Republic of", "facility"=>"Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "overallOfficials"=>[{"name"=>"Young-Guk Ko, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
