[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Intervene, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100600297","recana-ous---recana-thrombectomy-catheter-system-for-venous-obstruction-and-occlusion-study-recana-ous-irl-100600297",false,"NCT07095660","RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form;\n2. Participant is 18 years of age and older;\n3. Neurologically stable;\n4. Ambulatory;\n5. Symptomatic chronic venous disease (CVD) with edema (CEAP classification of C3 or greater) or pain;\n6. Flow-limiting venous outflow obstruction (\\>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and\n7. Target treatment IVC\u002FCommon Iliac confluence to the deep veins above the knee.\n\nExclusion Criteria:\n\n1. Comorbidity risks which may limit longevity (\\\u003C2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);\n2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;\n3. History of stroke within the last 6 months;\n4. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);\n5. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks prior to consent;\n6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months prior to consent;\n7. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;\n8. Flow-limiting venous outflow obstruction central to the target\u002Ftreatment vessel that cannot be treated;\n9. Pregnant and\u002For breastfeeding;\n10. Patients with cognitive impairments who are unable to be consented;\n11. Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;\n12. COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk;\n13. Patients considered to belong to a vulnerable population; and\n14. Inability to secure venous access and cross lesion.","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic postthrombotic venous inflow\u002Foutflow obstruction. The main questions the clinical investigation aims to answer are:\n\n1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure\n2. primary efficacy endpoint: patency greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative\u002Fperiprocedural)\n\nParticipants are screened and qualified for the clinical investigation. Qualified participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.",[25],"Venous Obstruction",[27,28,29,30,31,32],"chronic venous disease","chronic venous insufficiency","CEAP classification of C3 or greater","flow-limiting venous outflow obstruction","postthrombotic syndrome","venous inflow\u002Foutflow obstruction","RECRUITING","2026-05-22",{"date":36,"type":37},"2026-05-27","ACTUAL",{"date":39,"type":37},"2025-07-02",{"date":41,"type":19},"2027-04-30",{"name":43,"class":44},"Intervene, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100633674","the-recana-for-lower-extremity-venous-obstructions-and-in-stent-restenosis-registry-100633674","NCT07529756","The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry","The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry (\"The CALIBER Registry\")","CALIBER","INCLUSION CRITERA:\n\nA. Native Vessel:\n\n1. INC-1: Subject is 18 years or older\n2. INC-2: Proximal lower extremity obstruction\u002Focclusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient\n3. INC-3: Recana Thrombectomy Catheter System must enter vasculature\n4. INC-4: Willing and able to provide written informed consent\n\nB. In-Stent Restenosis:\n\n1. INC-1: Subject is 18 years or older\n2. INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure\n3. INC-3: Location of thrombosed stents in proximal lower extremity deep vein segments including common femoral, external iliac, common iliac vein, or inferior vena cava alone or in combination that in the opinion of the investigator treatment with the Recana would benefit the patient\n4. INC-4: Recana Thrombectomy Catheter System must enter vasculature\n5. INC-5: Willing and able to provide written informed consent\n\nEXCLUSION CRITERA\n\nA. Native Vessel:\n\n1. EXC-1: IVC aplasia\u002Fhypoplasia or other congenital anatomic anomalies of the IVC or iliac veins\n2. EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure\n3. EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana\n4. EXC-4: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)\n5. EXC-5: Severe, life-threatening allergy to iodine or contrast dye\n6. EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n7. EXC-7: Life expectancy less than 1 year\n8. EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status\n9. EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period\n10. EXC-10: Inability to secure venous access and cross lesion\n11. EXC-11: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject\n12. EXC-12: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed\n\nB. In-Stent Restenosis:\n\n1. EXC-1: Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel\n2. EXC-2: Stent failure caused by undersizing or malapposition of the stent(s) \\[For example, the segment of a stent in the iliac vein that is not wall apposed or cannot be apposed to the wall after balloon dilation is excluded. The segment of a stent that extends into the IVC that is not wall apposed would not be excluded.\\]\n3. EXC-3: Stents compressed to \\\u003C6mm that remain \\\u003C6mm after balloon dilation\n4. EXC-4: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure\n5. EXC-5: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana\n6. EXC-6: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)\n7. EXC-7: Severe, life-threatening allergy to iodine or contrast dye\n8. EXC-8: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n9. EXC-9: Life expectancy less than 1 year\n10. EXC-10: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status\n11. EXC-11: Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n12. EXC-12: Inability to secure venous access and cross lesion\n13. EXC-13: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject\n14. EXC-14: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed",{"count":55,"type":19},87,"1 Year","OBSERVATIONAL","The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are:\n\n* What is the observed rate of safety events through the 30-day follow-up?\n* What is the rate of technical success (acute procedural success) achieved at the index procedure?\n\nParticipants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.",[60,61,62,63,64,65,66],"Chronic Venous Disease","Chronic Venous Insufficiency, CVI","Venous Thrombosis","Thrombosis (Stent Thrombosis)","Thrombosis, Venous","Embolism and Thrombosis","Thrombectomy",[68,69,70,71,72,73,74],"in-stent restenosis","venous obstruction or occlusion","thrombus","emboli","CALIBER Registry","recanalization","debulking","NOT_YET_RECRUITING","2026-05-07",{"date":78,"type":37},"2026-05-12",{"date":80,"type":19},"2026-06",{"date":82,"type":19},"2029-03",{"name":43,"class":44},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":20,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100609836","recana-ous---recana-thrombectomy-catheter-system-for-venous-obstruction-and-occlusion-study-recana-ous-uk-100609836","NCT07219758","RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form;\n2. Participant is 18 years of age and older;\n3. Neurologically stable;\n4. Ambulatory;\n5. Symptomatic chronic venous disease (CVD), with edema (CEAP classification of C3 or greater) or pain;\n6. Flow-limiting venous outflow obstruction (\\>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and\n7. Target treatment IVC\u002FCommon Iliac confluence to the deep veins above the knee.\n\nExclusion Criteria:\n\n1. Comorbidity risks which may limit longevity (\\\u003C2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);\n2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;\n3. History of stroke within the last 6 months;\n4. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);\n5. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks prior to consent;\n6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months prior to consent;\n7. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;\n8. Flow-limiting venous outflow obstruction central to the target\u002Ftreatment vessel that cannot be treated;\n9. Pregnant and\u002For breastfeeding;\n10. Patients with cognitive impairments who are unable to be consented;\n11. Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;\n12. COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk;\n13. Patients considered to belong to a vulnerable population; and\n14. Inability to secure venous access and cross lesion.",{"count":91,"type":19},30,[22],"The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic post-thrombotic venous inflow\u002Foutflow obstruction. The main questions the clinical investigation aims to answer are:\n\n1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure\n2. primary efficacy endpoint: greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative\u002Fperiprocedural)\n\nParticipants are screened and qualified for the clinical investigation. Qualifed participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.",[25],[27,28,29,30,96,32],"post-thrombotic syndrome (PTS)","2026-05-01",{"date":99,"type":37},"2026-05-06",{"date":101,"type":37},"2025-10-18",{"date":103,"type":19},"2027-07",{"name":43,"class":44},""]