[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633674":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":38,"locations":10,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":59,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":70,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":10},{"fullName":5,"class":6},"Intervene, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Analysis Set (PAS) Population",null,"The Primary Analysis Set (PAS) population is a subset of the Full Analysis Set (FAS) population with unilateral or bilateral venous obstructions or occlusions without recent (≤3 months) venous intervention. The first 87 subjects in the FAS population who meet these criteria will complete the Primary Analysis Set population.",[13],"Device: Recanalization and debulking",{"label":15,"type":10,"description":16,"interventionNames":17},"Full Analysis Set (FAS) Population","The Full Analysis Set (FAS) population is defined as all consented subjects who are determined to be are appropriate candidates for treatment with the Recana Thrombectomy Catheter System and undergo the study procedure. The study will consist of up to 500 subjects in the FAS population.",[13],{"label":19,"type":10,"description":20,"interventionNames":10},"Intention to Treat (ITT) Population","The Intention-to-Treat (ITT) population is defined as all consented subjects who are determined to be candidates for treatment with the Recana Thrombectomy Catheter System, independent of the procedure being initiated or completed.",[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DEVICE","Recanalization and debulking","Recanalization and debulking with the Recana Thrombectomy Catheter System",[15,9],[28,32,35],{"name":29,"affiliation":30,"role":31},"William A Marston, MD","University of North Carolina","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Kush R Desai, MD","Northwestern University",{"name":36,"affiliation":37,"role":31},"Sameh Sayfo, MD, MBA","Baylor Scott & White The Heart Hospital - Plano",[39],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Clinical Affairs Team","CONTACT","650-995-7137","ClinSupport@intervene-med.com",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100633674","the-recana-for-lower-extremity-venous-obstructions-and-in-stent-restenosis-registry-100633674",false,"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","ALL","18 Years",{"count":57,"type":58},87,"ESTIMATED","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.",[63,64,65,66,67,68,69],"Chronic Venous Disease","Chronic Venous Insufficiency, CVI","Venous Thrombosis","Thrombosis (Stent Thrombosis)","Thrombosis, Venous","Embolism and Thrombosis","Thrombectomy",[71,72,73,74,75,76,77],"in-stent restenosis","venous obstruction or occlusion","thrombus","emboli","CALIBER Registry","recanalization","debulking","NOT_YET_RECRUITING","2026-05-07",{"date":81,"type":82},"2026-05-12","ACTUAL",{"date":84,"type":58},"2026-06",{"date":86,"type":58},"2029-03",{"name":5,"class":6}]