[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abdominal-aortic-aneurysm-without-rupture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abdominal-aortic-aneurysm-without-rupture":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,81,108,136],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100431190","phase-4-opioid-free-anesthesia-analgesia-strategy-and-surgical-stress-in-elective-open-abdominal-aortic-aneurysm-repair-100431190",false,"NCT04894864","Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair","Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study","Inclusion Criteria:\n\n1. Patient Consent\n2. Age between 40 and 85 years old\n3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair\n\nExclusion Criteria:\n\n1. Immunocompromised patients\n2. Patients with active infection\n3. Reoperation on the aorta\n4. Inflammatory bowel Disease\n5. Malignancy\n6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)\n7. Chronic corticosteroid or immunosuppressive drug use\n8. Intraoperative transfusion with \\>2 units of packed Red Blood Cells","ALL","40 Years","85 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity\u002Fmortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international \"opioid-crisis\" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic\u002Fanalgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects.\n\nOur basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.",[27,28,29,30,31,32,33,34],"Elective Surgical Procedures","Postoperative Pain","Anesthesia","Opioid Use","Abdominal Aortic Aneurysm Without Rupture","Vascular Surgical Procedure","Interleukin 6","Immunomodulators",[36,37,38,39,40,41,42],"Opioid-free Anesthesia-Analgesia","Cytokines","Opioid-based Anesthesia-Analgesia","Haemodynamic Stability","Open Abdominal Aortic Aneurysm Repair","Immunomodulation","Inflammatory Markers","RECRUITING","2026-06-13",{"date":46,"type":47},"2026-06-16","ACTUAL",{"date":49,"type":47},"2020-10-08",{"date":51,"type":21},"2027-09-01",{"name":53,"class":54},"University of Crete","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100541672","shockwaveperipheral-intravascular-lithotripsy-balloon-for-advanced-endovascular-aortic-repair-100541672","NCT06332911","Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","TEVAR","Inclusion Criteria:\n\n1. Patient (m\u002Ff) age ≥ 18 years at time of enrollment.\n2. Diagnosis of thoracic and\u002For thoraco-abdominal (Extent I-V) and juxta\u002Fpara-renal\u002Fshort-neck aneurysm requiring the implantation of a thoracic and\u002For thoraco-abdominal fenestrated\u002Fbranched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).\n3. Hostile iliac access was defined in the presence of:\n\n   * Heavily circumferential calcified iliac arteries\n   * Inner diameter ≤ 6 mm\n   * Severe stenosis (\\> 50%; \\> 2.5 m\u002Fs peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)\n4. We will accept the following presentations of aneurysm:\n\n   * urgent cases,\n   * elective,\n   * symptomatic\n   * and fast growing.\n5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and\u002For stent and stent-graft positioning.\n\nExclusion Criteria:\n\n1. Patients submitted to surgical conduit bypass.\n2. Not-severely calcified disease (absence of calcification).\n3. In-stent restenosis\u002Focclusion.\n4. Inability to cross with 0.014 guidewire.\n5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.\n6. Pre-stented iliac access vessels at the level of Shockwave implementation.","18 Years",{"count":66,"type":21},30,"OBSERVATIONAL","Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.\n\nThe aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F\u002FBEVAR.",[70,31,71],"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture","Thoracic Aortic Aneurysm Without Rupture","2025-05-19",{"date":74,"type":47},"2025-05-23",{"date":72,"type":47},{"date":77,"type":21},"2027-05-30",{"name":79,"class":80},"Rede Optimus Hospitalar SA","NETWORK",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":55},"100582704","efficacy-of-biomarkers-and-ceus-versus-cta-in-aaa-follow-up-post-evar-100582704","NCT06866769","Efficacy of Biomarkers and CEUS Versus CTA in AAA Follow-up Post-EVAR","Comparación De La Eficacia Entre Biomarcadores Y Ecografía Con Contraste Frente a Angio-TC En El Seguimiento De Aneurismas De Aorta Abdominal (AAA) Tras Reparación Endovascular (EVAR)","EVAR-markers","Inclusion Criteria:\n\n* patients with AAA under follow-up who are going to be treated with EVAR.\n* signed informed consent to perform CTA, CEUS and for the determination of biomarkers.\n\nExclusion Criteria:\n\n* patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.",{"count":90,"type":21},60,"This prospective observational study evaluates the efficacy of contrast-enhanced ultrasound and biomarker determination in the follow-up of patients with abdominal aortic aneurysm (AAA) treated with Endovascular Aneurysm Repair (EVAR). Currently, computed tomography angiography (CTA) is the standard for follow-up, although it has disadvantages such as radiation exposure and the use of iodinated contrasts. Contrast-enhanced ultrasound (CEUS), free of radiation and nephrotoxicity, and biomarkers could reduce the need for CTA minimizing the associated risks. Biomarkers will be measured before and after EVAR and CEUS will be performed at various time points and compared with CTA results to validate concordance and effectiveness in detecting endoleaks and aneurysm remodeling. The objectives include determining the efficacy of these combined methods and establishing a follow-up protocol that reduces exposure to radiation and iodinated contrast agents.",[31],[94,95,96,97,98],"Abdominal Aortic Aneurysm (AAA)","Endovascular Aneurysm Repair (EVAR)","Contrast-enhanced ultrasound (CEUS)","Computed tomography angiography (CTA)","Biomarkers.","2025-03-05",{"date":101,"type":47},"2025-03-10",{"date":103,"type":47},"2024-07-25",{"date":105,"type":21},"2028-04-30",{"name":107,"class":54},"Instituto de Investigacion Sanitaria La Fe",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":55},"100559949","iops-technology-during-cannnulation-of-contralateral-limb-in-evar-100559949","NCT06570785","IOPS Technology During Cannnulation of Contralateral Limb in EVAR","Contralateral Limb Cannulation Using Intra-Operative Positioning SystemTechnology in Endovascular Aneurysm Repair","IOPS","Inclusion Criteria:\n\n\\- All patients (over 18 years of age) with infrarenal AAA treated between 1st September 2024 and 1st May 2025 undergoing standard EVAR according to the IFU\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are under 40 years of age\n* Patients who have symptomatic or ruptured AAA\n* Patients with more advanced AAA: juxtarenal, pararenal, suprarenal, thoracic, thoracoabdominal AAA\n* Non-atherosclerotic origin of disease: dissection, connective tissue disorders, mycotic AAA, posttraumatic AAA\n* Patients who were treated in a conservative manner\n* Patients undergoing open surgery\n* Patients undergoing more advanced treatment options: fenestrated\u002Fbranched EVAR, endostaplers, chimney EVAR, iliac branch devices, etc.","100 Years",{"count":118,"type":21},80,"Short-term results are favorable for EndoVascular Aneurysm Repair (EVAR) compared to open surgery. One of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices. The use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation. Because of the harmful effects of radiation, recent radiation protection guidelines strongly recommend as low as reasonably achievable (ALARA) principle. The need for additional radiation-reducing navigation techniques is high, with the ultimate goal of performing endovascular procedures without radiation at all.\n\nIn response to these challenges, Centerline Biomedical (Cleveland, Ohio, USA) has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System (IOPS). This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.\n\nThis study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb (CL) during standard EVAR.",[121,31,122],"Abdominal Aortic Aneurysm","Radiation Exposure",[121,124,125],"EndoVascular Aneurysm Repair","Radiation Protection","NOT_YET_RECRUITING","2024-11-17",{"date":129,"type":47},"2024-11-20",{"date":131,"type":21},"2025-01-20",{"date":133,"type":21},"2025-11-03",{"name":135,"class":54},"Clinical Centre of Serbia",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":116,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100483479","pre-emptive-abdominal-aortic-aneurysm-sac-embolization-during-evar-100483479","NCT05575570","Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR","Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study","Inclusion Criteria:\n\n* Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR\n* \\> 18 year old\n\nExclusion Criteria:\n\n* Not accept to participate\n* Ruptured AAA\n* Outside for instruction for the use EVAR",{"count":144,"type":21},124,[146],"NA","Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study",[31],[150,151,152,153],"AAA","Embolization","Endoleak","sac regression","2024-04-08",{"date":156,"type":47},"2024-04-10",{"date":158,"type":21},"2024-11-01",{"date":160,"type":21},"2028-01-01",{"name":162,"class":54},"Rigshospitalet, Denmark"]