[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573011":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":29,"eligibilityCriteria":30,"healthyVolunteers":25,"sex":31,"minAge":32,"maxAge":20,"enrollmentInfo":33,"targetDuration":20,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":20,"overallStatus":42,"whyStopped":20,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":20},{"fullName":5,"class":6},"Shape Memory Medical, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Intervention","EXPERIMENTAL","Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill",[13],"Device: False Lumen Embolization System, IMPEDE-FX RapidFill",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","False Lumen Embolization System, IMPEDE-FX RapidFill","Embolization of the false lumen of an aortic dissection",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100573011","false-lumen-treatment-for-prevention-of-aortic-growth-using-shape-memory-polymer---first-in-human-study-flagshipfra-100573011",false,"NCT06740721","False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)","False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study","FLAGSHIP_FRA","Inclusion Criteria:\n\n* ≥18 years of age.\n* A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear\u002FTL treatment, OR\n* A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear\u002FTL was treated in a previous procedure, and is now presenting with a FL requiring treatment.\n\nExclusion Criteria:\n\n* An inability to provide informed consent.\n* Enrolled in another clinical study other than a registry.\n* Hyperacute or acute aortic dissection (\\\u003C15 days from symptom onset).\n* Untreated or uncovered primary entry\u002Freentry tear proximal to left subclavian artery (before FL treatment with the investigational product).\n* Vascular disease, aortic rupture, and\u002For anatomy and\u002For dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.\n* Prior treatment of the FL.\n* Planned use of investigational devices to treat the primary entry tear and\u002For TL.\n* Absence of\u002Finability to create a reentry tear\u002Ffenestration adequately positioned and large enough to allow introducer sheath access into the FL.\n* Planned use of FL embolic devices other than the investigational product.\n* Prior abdominal aortic aneurysm (AAA) treatment.\n* Planned concomitant major surgery (e.g., gastrointestinal surgery).\n* Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome).\n* Coagulopathy or uncontrolled bleeding disorder.\n* Serum creatinine level \\>2.5 mg\u002FdL (within 90 days prior to the procedure).\n* Cerebrovascular accident within 90 days prior to the procedure.\n* Myocardial infarction and\u002For major heart surgery within 90 days prior to the procedure.\n* Atrial fibrillation that is not well rate controlled.\n* Unable or unwilling to comply with study follow-up requirements.\n* Life expectancy of \\\u003C2 years postprocedure.\n* Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.\n* A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.\n* History of allergy to contrast medium that cannot be managed medically.\n* Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.\n* Participant is planning to become pregnant or is currently pregnant or lactating. For participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.","ALL","18 Years",{"count":34,"type":35},15,"ESTIMATED","INTERVENTIONAL",[38],"NA","To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.",[41],"Aortic Dissection","NOT_YET_RECRUITING","2026-01-27",{"date":45,"type":46},"2026-01-29","ACTUAL",{"date":48,"type":35},"2026-10-01",{"date":50,"type":35},"2029-01-03",{"name":5,"class":6}]