[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortoiliac-occlusive-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortoiliac-occlusive-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,67,89,123],{"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":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644498","predictors-of-major-adverse-limb-events-after-endovascular-iliac-stenting-a-real-world-cohort-study-100644498",false,"NCT07672249","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study (PREMISE-ILIAC Study)","PREMISE-ILIAC","Inclusion Criteria:\n\nAdult patients aged ≥18 years, of both male and female sex\n\n* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and\u002For external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography\n* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy\n* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy\n* De novo iliac lesions only\n* Availability of complet\n\nExclusion Criteria:\n\nPrimary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).\n\n* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).\n* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).\n* Hybrid procedures with concomitant infrainguinal bypass surgery.\n* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.\n* Loss to follow-up without documented clinical outcomes.","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","OBSERVATIONAL","Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.\n\nDespite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.\n\nThis retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.",[25,26,27,28],"Peripheral Arterial Disease","Aortoiliac Occlusive Disease","Chronic Limb-Threatening Ischemia","Intermittent Claudication",[25,30,31],"Iliac Artery Stenting","Endovascular Revascularization","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2026-06-16",{"date":40,"type":21},"2026-07-16",{"name":42,"class":43},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100583175","real-world-data-collection-of-the-gore-viabahn-vbx-balloon-expandable-endoprosthesis-when-used-in-covered-endovascular-reconstruction-of-the-aortic-bifurcation-cerab-to-treat-aortoiliac-occlusive-disease-100583175","NCT06872905","Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease","Inclusion Criteria:\n\n1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).\n2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.\n3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.\n4. Age ≥18 years at the time of CERAB procedure.\n5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)\u002FEthics Committee (EC) -\n\nExclusion Criteria:\n\n1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.\n2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).\n3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.\n\n   \\-","100 Years",{"count":53,"type":21},158,"The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (\"VBX Device\" or also referred to as \"VBX Stent Graft\") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).",[26],"2026-05-27",{"date":58,"type":36},"2026-05-29",{"date":60,"type":36},"2025-05-30",{"date":62,"type":21},"2027-08-16",{"name":64,"class":65},"W.L.Gore & Associates","INDUSTRY",25,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100501600","the-gore-vbx-forward-clinical-study-a-comparison-of-the-gore-viabahn-vbx-balloon-expandable-endoprosthesis-to-bare-metal-stenting-for-patients-with-complex-iliac-occlusive-disease-100501600","NCT05811364","The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease","Inclusion Criteria:\n\n* Age ≥ 18 years at time of informed consent signature\n* Informed Consent Form (ICF) is signed by the subject\n* Subject can comply with protocol requirements, including follow-up\n* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)\n* Patient has de novo or restenotic lesion(s) found in the common and\u002For external iliac artery(ies)\n* Patient has: Unilateral or bilateral single or multiple lesions (\\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length\n* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm\n* Patient has a sufficient (\\\u003C50% stenotic) common femoral artery and at least one sufficient (\\\u003C50% stenotic) femoral artery (deep or superficial).\n* Patient has at least one sufficient (\\\u003C50% stenotic) infrapopliteal run-off vessel.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year\n* Patient is pregnant at time of informed consent.\n* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).\n* Patient has severe chronic renal insufficiency (serum creatinine level \\> 2.5mg\u002FdL) and not undergoing hemodialysis.\n* Patient has evidence of a systemic infection.\n* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.\n* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).\n* Patient has previous stenting in the iliac arteries.\n* Patient has previous surgical bypass in the target limb.\n* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.\n* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.\n* Patient has an abdominal aortic artery lesion or aneurysm.\n* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.\n* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).\n* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral \u002F tibial revascularization).",{"count":74,"type":21},244,"INTERVENTIONAL",[77],"NA","The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.",[26,25],"2026-05-11",{"date":82,"type":36},"2026-05-13",{"date":84,"type":36},"2023-10-17",{"date":86,"type":21},"2032-01-31",{"name":64,"class":65},43,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":75,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"100513941","phase-4-liposomal-bupivacainebupivacaine-in-rectus-sheath-blocks-versus-ropivacaine-in-rectus-sheath-blocks-and-catheters-100513941","NCT05972018","Liposomal Bupivacaine\u002FBupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters","Liposomal Bupivacaine\u002FBupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Versus Ropivacaine in Bilateral Rectus Sheath Blocks And Catheters With Intermittent Hourly Boluses.","EXODUS","Inclusion Criteria:\n\n1. Patients aged 18-80 years\n2. Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision, including abdominal aortic aneurysm repair surgery (AAA), mesenteric artery bypass surgery, and aortobifemoral bypass surgery for aortic occlusive disease.\n3. Patients who are able to speak and read English\n4. Patients with American Society of Anesthesiology (ASA) physical status score I-IV\n5. Patients who are admitted to the hospital and are incidentally discovered to require any of the aforementioned surgeries, being asymptomatic for vascular issues, and having their surgery scheduled no sooner than three days after admission, are also considered eligible.\n\nExclusion Criteria:\n\n1. Emergency vascular reconstruction surgery., patients admitted to the hospital due to symptoms directly associated with their vascular condition, such as severe abdominal pain or a ruptured aneurysm causing bleeding, will be excluded.\n2. Patients with contraindications to RSB, including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral RSBs, or infection at the injection site.\n3. History of allergy to local anesthetics.\n4. Weight \\\u003C 40 kg, as a combination of 20 mL of Bupivacaine 0.25% with 30 mL of LB is greater than the maximal dose allowed, given concern for local anesthetic toxicity.\n5. Patients who take long-acting opioid medication, or on continuous opioid use \\> 50 MME per day for at least 30 days within 90 days prior to surgery.\n6. Patients who have chronic pain syndrome with a recent preoperative consultation with the chronic pain service. Also, patients with distant metastatic cancers (e.g. bone, lung, brain) confirmed by CT scan.\n7. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs (not including marijuana) or excessive alcohol consumption as defined as 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.\n8. Lack or refusal to sign the study consent.\n9. Patients who are unable to receive postoperative ropivacaine intermittent boluses within the first 5 days after surgery due to issues with their catheter (such as dislodgement, migration, or kinking) will be excluded from the final analysis.\n10. Patients with a plan to undergo abdominal wall surgery, in addition to the vascular surgery that involves a mid-abdomen incision, such as abdominal wall reconstruction surgery. The additional abdominal wall incisions or interventions might have an impact on the study's pain, opioid, and LOS outcomes.","80 Years",{"count":99,"type":21},14,[101],"PHASE4","The goal of this pilot study is to compare single shot rectus sheath blocks of liposomal bupivacaine\u002Fbupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will assess the safety and feasibility of this approach compared to standard of care.\n\nParticipants will receive either a single dose of liposomal bupivacaine\u002Fbupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB\u002FB group) or the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for differences in the rate of postoperative complications, resources consumed with each intervention, as well as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery, and hospital length of stay.",[104,105,26,106],"Aortic Aneurysm, Abdominal","Abdominal Aortic Occlusion","Aortic Diseases",[108,109,110,111,112,113],"Open abdominal aortic repair surgery","Rectus Sheath Block","Rectus Sheath Block and Catheter","Liposomal Bupivacaine","Exparel","Ropivacaine continuous infusion","2025-08-28",{"date":116,"type":36},"2025-09-03",{"date":118,"type":36},"2023-10-18",{"date":120,"type":21},"2026-12-30",{"name":122,"class":43},"Hartford Hospital",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":44},"100535552","treatment-of-tasc-c-and-d-aortoiliac-lesions-100535552","NCT06253312","Treatment of TASC C and D Aortoiliac Lesions","Comparison of Open Surgery, Hybrid and Endovascular Repair for Complex TASC C\u002FD Aortoiliac Lesions","Inclusion Criteria:\n\n* All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022\n* All management strategies will be included (endovascular, hybrid, and open)\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are under 18 years of age\n* Patients who have acute limb ischemia or acute on chronic ischemia\n* Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection\n* Patients who were treated in conservative manner\n* Patients who underwent primary major amputation\n* Patients with limited life expectancy (less than 2 years)",{"count":131,"type":21},900,"Background:\n\nThe treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR.\n\nAim:\n\nThe aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions.\n\nMethodology:\n\nThis is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data.\n\nEndpoints:\n\nPrimary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.",[25,26,134,135],"Leriche Syndrome","Peripheral Vascular Disease",[137,138,139,140,141,142,143],"peripheral arterial disease","aortoiliac disease","TASC C,D","open surgery","hybrid repair","endovascular repair","atherosclerosis","2024-08-21",{"date":146,"type":36},"2024-08-23",{"date":148,"type":36},"2024-05-01",{"date":150,"type":21},"2025-09-01",{"name":152,"class":43},"Clinical Centre of Serbia"]