[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iVascular S.L.U.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,73,96,117,138],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636920","efficacy-and-safety-evaluation-of-instroke-5f-aspiration-catheter-for-thrombectomy-100636920",false,"NCT07571954","Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy","Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the Instroke 5F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke.","iNFLOW-5","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.\n* Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).\n* Baseline NIHSS score ≥ 6 assessed before the procedure.\n* Pre-stroke mRS score ≤ 2.\n* Subjects with an ASPECTS score ≥ 6.\n* Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).\n* France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent.\n\nExclusion Criteria:\n\n* Severe comorbidity and\u002For shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.\n* Severe allergy to contrast media.\n* Women of child-bearing potential.\n* Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.\n* Medical history of thrombocytopenia (Platelets \\\u003C100,000).\n* Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).\n* Subjects with occlusions in multiple vessels.\n* Subjects with cancer who have a life expectancy of less than 6 months.\n* Pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.\n* Severe sustained hypertension (systolic pressure \\>185 mm Hg or diastolic pressure \\>110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the subject may be included.\n* Known or suspected cerebral vasculitis.\n* Known renal insufficiency with creatinine ≥3 mg\u002Fdl or Glomerular Filtration Rate (GFR) \\\u003C30 mL\u002Fmin.\n* Current participation in an interventional drug or device study that may confound the results of this study.\n* Intracranial stenosis proximal to the occlusion.\n* France-specific exclusion criteria: As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke",[27],"Acute Ischemic Stroke",[29,30,31],"Stroke","Thromboaspiration","Ischemia","NOT_YET_RECRUITING","2026-05-08",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":21},"2026-08-31",{"date":40,"type":21},"2027-11-30",{"name":42,"class":43},"iVascular S.L.U.","INDUSTRY",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100633637","clinical-performance-and-safety-assessment-of-the-use-of-icover-balloon-expandable-covered-stent-ivascular-implanted-as-bridging-stent-in-fevar-fenestrated-endovascular-aortic-repair-for-the-treatment-of-complex-abdominal-aortic-aneurysms-100633637","NCT07529275","Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms","fenCo","Inclusion Criteria:\n\n1. Patient suitable for treatment of a juxta, para-renal, suprarenal or thoracoabdominal aneurysm with a fenestrated endoprosthesis in accordance with current indications and guidelines for the management of abdominal aortic aneurysms (aneurysm \\> 5 centimetres for women and \\> 5.5 centimetres for men and\u002For growth \\> 5 mm in 6 months or 1 centimetre in 1 year).\n2. The fenestrated endograft must be designed in a way that positions the fenestrations directly in front of the orifice of the target vessel, ensuring that the distance between the fenestration and the orifice of the target vessel does not exceed 5 mm.\n3. Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted:\n\n   1. Cook Medical: Zenith Fenestrated AAA Endovascular Graft\n   2. Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts\n   3. JOTEC (part of Artivion): E-xtra design engineering.\n4. Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration).\n5. Landing zone in the target vessel of at least 10 mm.\n6. Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm.\n7. Angulation of the aorta at the level of the target vessels \\\u003C 45 degrees.\n8. No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions.\n9. Age \\> 55 years.\n10. Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times.\n11. Patient affiliated to or benefiting from a social security system.\n12. Patient with life expectancy \\> 12 months.\n\nExclusion Criteria:\n\n1. Patients contraindicated for anti-platelet therapy.\n2. Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.\n3. Chronic or acute aortic dissection.\n4. Patients refusing treatment.\n5. Patients who are pregnant or wish to become pregnant.\n6. Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure.\n7. Patients considered hemodynamically unstable or requiring emergency treatment.\n8. Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery.\n9. Thrombus in the aortic sealing zone and target arteries with thickness \\> to 3 mm.\n10. Stenosis (\\>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow.\n11. Patients allergic to stent materials (L605) and\u002For PTFE.\n12. Patients requiring a hybrid aortic technique with branches, semibranches or chimneys.\n13. Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery.\n14. Patients with infectious\u002Fmycotic aneurysms.\n15. Angulation between renal artery and aortic wall \\\u003C 30 degrees.\n16. Patients with complex iliac accesses out the IFUs of the fenestrated endograft chosen to be implanted (COOK Medical \u002F Terumo Aortic\u002FJotec-Artivion) with the iCover Bridging stent.\n17. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period that may interfere with the results of this study.\n18. Myocardial infarction or stroke within 3 months prior to the procedure.\n19. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4.\n20. Patients with ASA classification 5 or higher.\n21. Patients with physician modified endografts or in situ laser FEVAR.","55 Years",{"count":54,"type":21},165,[24],"fenCo is a European multicentre, prospective study to evaluate the use of the iCover covered stents as bridging stents for reno-visceral target vessel during fEVAR for the treatment of complex abdominal aortic aneurysms.",[58],"Complex Abdominal Aortic Aneurysms",[60,61,62],"FEVAR","bridging stent","complex abdominal aortic aneurysms","RECRUITING","2026-04-13",{"date":66,"type":36},"2026-04-14",{"date":68,"type":36},"2026-02-16",{"date":70,"type":21},"2028-09-30",{"name":42,"class":43},24,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100621886","evaluation-of-instroke-aspiration-catheters-for-thrombectomy-a-multi-center-prospective-study-100621886","NCT07376447","Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study","Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke","iNDUO","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age.\n2. Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).\n3. Demonstrated occlusion in a large and\u002For medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).\n4. Baseline NIHSS score ≥6 assessed before the procedure.\n5. Pre-morbid \\[xB13.1\\]stroke baseline mRS ≤ 2.\n6. Subjects with an ASPECTS ≥ 6.\n7. Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.\n8. As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).\n\nExclusion Criteria:\n\n1. Severe comorbidity and\u002For shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.\n2. Severe allergy to contrast media.\n3. As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.\n4. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.\n5. Multiple Intracranial Occlusions\n6. Known medical history of thrombocytopenia (Platelets \\\u003C100,000).\n7. Presence of intracerebral hemorrhage.\n8. Significant mass effect and\u002For midline shift.\n9. Evidence of intracranial tumor (except small meningioma).\n10. Intracranial stenosis proximal to the occlusion.\n11. Severe sustained hypertension (systolic pressure \\>185 mm Hg or diastolic pressure \\>110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.\n12. Known or suspected cerebral vasculitis.\n13. Known renal insufficiency with creatinine ≥3 mg\u002Fdl or Glomerular Filtration Rate (GFR) \\\u003C30 mL\u002Fmin.\n14. Current participation in an interventional drug or device study that may confound the results of this study.",{"count":82,"type":21},160,[24],"Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke",[27],[29,31,30],"2026-01-29",{"date":89,"type":36},"2026-02-02",{"date":91,"type":21},"2026-05-31",{"date":93,"type":21},"2027-12-31",{"name":42,"class":43},11,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":116,"locationsCount":95},"100620412","safety-and-efficacy-evaluation-of-the-instroke-4f-thromboaspiration-catheter-in-patients-with-acute-ischaemic-stroke-due-to-primary-distal-medium-vessel-occlusions-dmvo-100620412","NCT07357285","Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)","Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).","4-NiVO","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Subjects with symptom onset up to 24 hours.\n* Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).\n* Baseline NIHSS score ≥5 assessed before the procedure.\n* Pre-stroke mRS score ≤ 2.\n* Subjects with an ASPECTS score ≥ 6.\n* Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).\n\nExclusion Criteria:\n\n* Subjects aged \\\u003C 18.\n* Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.\n* Baseline NIHSS score \\\u003C5 assessed before the procedure.\n* Pre-stroke mRS score \\>2.\n* Subjects with an ASPECTS score \\\u003C6.\n* Severe comorbidity and\u002For shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.\n* Severe allergy to contrast media.\n* Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.\n* Medical history of thrombocytopenia (Platelets \\\u003C100,000).\n* Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).\n* Subjects with occlusions in multiple vessels (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.\n* Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.\n* Subjects participating in a clinical trial at the moment of the inclusion.\n* Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.",{"count":105,"type":21},57,[24],"Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.",[27],[29,31,30],"2026-01-22",{"date":112,"type":36},"2026-01-23",{"date":114,"type":36},"2025-11-27",{"date":38,"type":21},{"name":42,"class":43},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":5},"100508630","investigating-the-safety-and-clinical-performance-of-eight-ivascular-devices-for-endovascular-intervention-in-renal-iliac-or-femoral-arteries-100508630","NCT05902923","Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries","A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.","Inclusion Criteria:\n\n* Corresponding to the CE-mark indications\u002Fcontra-indications and according to the IFU of the device.\n* Patient is \\>18 years old.\n* Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.\n* Target lesion(s) is\u002Fare located in renal, iliac or femoral arteries.\n* Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and\u002For the Oceanus 35 Balloon Dilatation Catheter and\u002For the Luminor 18 Drug Coated Balloon and\u002For the Luminor 35 Drug Coated Balloon and\u002For the Restorer Peripheral Stent System and\u002For the iVolution pro Peripheral Self-Expanding Stent System and\u002For the iCover Covered Peripheral Stent System and\u002For the Sergeant Peripheral Support Catheter as described in IFU for each device.\n\nExclusion Criteria:\n\n* Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.\n* Known contraindication and\u002For allergy to (a component of) an investigational device.\n* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.\n* Life expectancy of less than 12 months.\n* Any planned surgical intervention\u002Fprocedure within 30 days after the study procedure.\n* Any patient considered to be hemodynamically unstable at onset of the procedure.",{"count":125,"type":21},209,"OBSERVATIONAL","The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.",[129],"Artery Disease","2024-05-06",{"date":132,"type":36},"2024-05-08",{"date":134,"type":36},"2023-08-01",{"date":136,"type":21},"2027-08",{"name":42,"class":43},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":147,"studyType":126,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100419550","european-all-comers-multicentric-prospective-registry-on-luminor-drug-eluting-balloon-in-the-superficial-femoral-artery-and-popliteal-artery-with-5-years-follow-up-100419550","NCT04743180","European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.","LUMIFOLLOW","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Rutherford Clinical Category 2-5\n* The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)\n* Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery\n* TASC II Class A to D Lesions\n* de novo lesion(s), non-stented or stented restenotic lesion(s)\n* Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation\n* Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)\n* A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication\n* Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use\n* At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children\n* Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)\n* Life expectancy of \\\u003C 1year\n* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study\n* Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication\n* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel",{"count":146,"type":21},500,"60 Months","The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and\u002For long lesions\u002Focclusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.",[150,151,152,153,154],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","Paclitaxel","2021-02-10",{"date":157,"type":36},"2021-02-11",{"date":159,"type":36},"2021-01-18",{"date":161,"type":21},"2026-06-30",{"name":42,"class":43},15,""]