[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steno-occlusive-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steno-occlusive-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100637391","phase-4-effect-of-dexmedetomidine-on-hemodynamic-stability-in-carotid-endarterectomy-reduced-norepinephrine-use-and-propofol-dosing-via-central-sympatholytic-action-100637391",false,"NCT07597109","Effect of Dexmedetomidine on Hemodynamic Stability in Carotid Endarterectomy: Reduced Norepinephrine Use and Propofol Dosing Via Central Sympatholytic Action","Does the Co-administration of Dexmedetomidine Improve Hemodynamic Stability During Carotid Endarterectomy (CEA) Under General Anaesthesia? A Single-Centre Prospective Randomized Controlled Trial.","Inclusion Criteria:\n\n* age ≥18 years\n* ASA physical status 1-4\n* written informed consent provided.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years, Rapid sequence induction needed for surgery, higher grade atrioventricular block without pacemaker, severe hypovolaemia or bradycardia, uncontrolled hyper or hypotension, hypersensibility concerning the active substance Dexmedetomidine or any other component, serve liver disease, known malignant hyperthermia, cardiovascular instability or severe heart failure (EF ≤ 30% or \\> NYHA III), limited peripheral autonomic activity, pregnancy, rejection or lack of consent of the patient.","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","1. Objective and Selection We refer to our research project as the \"research project\" in this information sheet. If you participate, you will be a participant.\n\n   In this research project, we aim to investigate the effect of the medication dexmedetomidine on blood pressure during surgery on your carotid artery. We are inviting you because all individuals undergoing carotid artery surgery may participate.\n2. General Information Due to your narrowing of the carotid artery, you require a planned procedure under general anesthesia. During this, your circulatory system and heart function will be continuously monitored through ongoing measurements to constantly track your condition. At the start of general anesthesia, heart rate, blood oxygen levels, and blood pressure will be monitored. Strong painkillers and anesthetic agents will then be administered for the general anesthesia. Additional medications will be given to maintain the anesthesia. Your condition will be closely and continuously monitored throughout the general anesthesia. At the end of the surgery, the anesthetic agents will be gradually reduced, allowing you to awaken from the anesthesia. In this context, we want to examine whether the additional administration of dexmedetomidine during carotid artery surgery reduces blood pressure fluctuations that may occur during such anesthesia.\n\n   The medication dexmedetomidine is approved for the Swiss market by Swissmedic and is commonly used today in many areas of anesthesia and intensive care medicine. It is even administered to pediatric patients in anesthesia. The goal of continuous dexmedetomidine administration during surgery is twofold: to reduce the need for other anesthetic agents while simultaneously minimizing blood pressure fluctuations that may arise during different surgical phases.\n\n   The scientific question is: Does additional administration of dexmedetomidine influence the intraoperative hemodynamic course and thus the clinical outcome after surgery? The study will be conducted over approximately 24 months at Inselspital Bern (single-center) with 44 patients. We are conducting this study in accordance with Swiss laws and all internationally recognized guidelines. The responsible cantonal ethics committee (KEK Bern, Murtenstrasse, Bern) has reviewed and approved the study. A description of this study is also available on the website of the Federal Office of Public Health: www.kofam.ch.\n3. Procedure The planned surgery will be performed independently of this study. Upon the patient's arrival in the operating room, they will be randomly assigned to one of two groups. One group will serve as the control group and receive standard general anesthesia according to our current hospital guidelines. The second group will receive the standard anesthesia plus the study medication dexmedetomidine in a precisely defined dose. Group allocation will be randomized and blinded (not disclosed to participants). The number of patients in both groups will be equal. Both groups will be treated and monitored in accordance with the recommendations and standards of the Department of Anesthesia and Pain Medicine at Inselspital Bern, as well as those of the Swiss Society for Anaesthesiology and Perioperative Medicine (SSAPM). Hemodynamic and cardiac function parameters will be closely monitored and recorded for all study participants. These data will be collected by the attending anesthesiologist.\n\nAt a precisely defined time point during the surgery (achievement of \"burst suppression\"), administration of the study medication will be stopped, and anesthesia will be adjusted according to surgical progress. After emergence from general anesthesia, you will be immediately assessed and then transferred to the recovery unit. During your stay on the recovery unit, circulatory parameters and your neurological status will be assessed at regular intervals.\n\nPrior to transfer to the regular ward the following day, a questionnaire regarding your neurological status will be completed, and all medications administered during your recovery unit stay will be recorded. The study will then be finished for all participating patients.",[26],"Steno-occlusive Disease","NOT_YET_RECRUITING","2026-05-12",{"date":30,"type":31},"2026-05-19","ACTUAL",{"date":33,"type":20},"2026-09-01",{"date":35,"type":20},"2028-09-30",{"name":37,"class":38},"Insel Gruppe AG, University Hospital Bern","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100619747","phase-3-evaluation-of-the-efficacy-and-safety-of-magnetic-resonance-angiography-mra-using-gadopiclenol-compared-to-gadoterate-meglumine-in-the-assessment-of-steno-occlusive-disease-in-adult-patients-with-suspected-vascular-disease-100619747","NCT07348640","Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease","A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease","Inclusion Criteria:\n\n1. Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol.\n2. Patient having read the information in the ICF and having provided his\u002Fher consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted.\n3. Patient with suspected steno-occlusive disease in supra-aortic (carotid\u002Fvertebrobasilar) (a), peripheral (b) or abdominal\u002Frenal (c) arteries based on:\n\n   1. clinical signs and symptoms including but not limited to prior stroke, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and\u002For previous diagnostic tests (CTA, IA-DSA, or ultrasound) or\n   2. symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and\u002For confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) or\n   3. suspected renovascular hypertension based on one or more of the following criteria:\n\n   i. hypertension refractory to standard therapy ii. acute worsening of pre-existing hypertension iii. abrupt onset of sustained, moderate to severe hypertension at age \\\u003C35 years suggestive of fibromuscular dysplasia (FMD) iv. progressive renal insufficiency (creatinine \\> 2 mg\u002FdL; no other apparent cause of progressive renal failure based on routine medical history, physical examination, 24-h urine collection and urinary protein excretion) v. abnormal\u002Finconclusive renal doppler ultrasound. vi. other criteria (to be specified)\n4. Are scheduled for or had undergone CTA and\u002For IA-DSA according to imaging standards to cover the supra-aortic (carotid\u002Fvertebrobasilar) and\u002For peripheral and\u002For abdominal\u002Frenal territory described in this protocol.\n\nExclusion Criteria:\n\n1. Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential:\n\n   * by testing on site at the institution (serum βHCG or urine)\n   * by surgical history (e.g., tubal ligation or hysterectomy)\n   * post-menopausal with a minimum 1 year without menses.\n2. Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.\n3. Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL\u002Fmin\u002F1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.\n4. Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg\u002FdL (≥ 26.5 μmol\u002FL) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within prior 7 days or c. Urine volume \\\u003C 0.5 mL\u002Fkg\u002Fh for 6 hours\n5. Has received any contrast agent (for MRI, CT, DSA) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or after the second IMP administration.\n6. Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA\u002FIADSA procedures when applicable.\n7. Has any contraindications to MRI.\n8. Is suffering from severe claustrophobia.\n9. Has received an investigational drug or medical device before admission into this study or scheduled to receive any investigational treatment in the course of the trial.\n10. Was previously included in this trial.\n11. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and\u002For post-dose follow-up examinations.",{"count":47,"type":20},315,[49],"PHASE3","Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal \u002F renal arteries using MRI",[26],[53,54,55],"steno-occlusive disease","gadopiclenol","Magnetic Resonnance Angiography","2026-01-16",{"date":58,"type":31},"2026-01-20",{"date":60,"type":20},"2026-02-02",{"date":62,"type":20},"2027-12-31",{"name":64,"class":65},"Guerbet","INDUSTRY",41]