[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ischemia-limb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ischemia-limb":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100605493","safety-of-the-iperf-femoral-arterial-cannula-in-patients-undergoing-planned-cardiac-surgery-with-extracorporeal-circulation-via-femoral-approach-100605493",false,"NCT07163234","Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach","First-In-Human Study (Phase I) Evaluating the Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing a Planned Cardiac Surgery Requiring the Use of an Extracorporeal Circulation Via a Femoral Approach for a Maximum of 6 Hours","FIH IPERF-01","Inclusion criteria\n\n* Patient aged 18 years or older\n* Patient able to understand the study procedures, provide written informed consent, and comply with study procedures\n* Patients with planned cardiac surgery requiring the use of an extracorporeal circulation via a femoral approach for a maximum of 6 hours.\n* Patient affiliated to the social security system\n\nExclusion criteria\n\n* Patient weighting less than 45 kg\n* Patient weighting more than 130 kg\n* Patient with common femoral artery diameter less or equal to 6 mm\n* Patient with a stenosis of the aorta, iliac artery, or femoral artery reducing their diameter of more than 50%\n* Patient with previous vascular or endovascular surgery of the iliac or femoral arteries\n* Patient participating in another interventional study\n* Patients with known arterial dissection\n* Patient who is pregnant at the time of enrollment\n* Patients under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a femoral approach for up to 6 hours. The iPerf device is a dual-lumen arterial cannula designed to provide systemic and lower limb perfusion during ECC, with the goal of reducing the risk of acute limb ischemia. The study will be conducted at a single center in France and will include 15 adult patients. Primary outcomes focus on procedure-related and late adverse events up to 30 days post-surgery. Secondary objectives include assessment of ischemic events, tissue oxygen saturation, and surgeon satisfaction with device handling. The study aims to demonstrate feasibility and safety of the iPerf cannula as an innovative solution for lower limb perfusion during femoral artery cannulation.",[27,28],"Cardiac Surgery","Ischemia Limb",[30,27],"Ischemia","RECRUITING","2026-02-25",{"date":34,"type":35},"2026-02-27","ACTUAL",{"date":37,"type":35},"2026-02-11",{"date":39,"type":21},"2026-08",{"name":41,"class":42},"IPERF SAS","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100522179","ischemia-detection-during-development-of-acute-compartment-syndrome-100522179","NCT06079255","Ischemia Detection During Development of Acute Compartment Syndrome","Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome","IDEA","Inclusion Criteria:\n\n* Must have a leg fracture that, perceived by the clinician, could give rise to later developing acute compartment syndrome condition.\n* Subject must be 18 years or more.\n* Able to sign informed consent.\n* Expected cooperation of the patients for the treatment and follow up\n\nExclusion Criteria:\n\n* Another study interfering with current study\n* Any reason why, in the opinion of the investigator, the patient should not participate.\n* Patients where a fasciotomy has already been decided should be performed","110 Years",{"count":53,"type":21},60,"OBSERVATIONAL","This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.",[28,57,58,59,60],"Blood Circulation Disorder","Carbon Dioxide","Biosensing Techniques","Compartment Syndrome of Leg",[30,62,63,64,65,66],"Biosensor","Carbon dioxide","Orthopedic surgery","Limb","Acute compartment syndrome","NOT_YET_RECRUITING","2025-03-21",{"date":70,"type":35},"2025-03-25",{"date":72,"type":21},"2025-10-15",{"date":74,"type":21},"2027-10-30",{"name":76,"class":77},"Oslo University Hospital","OTHER",1]