[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shape Memory Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,82],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100518370","aaa-shape-pivotal-trial-abdominal-aortic-aneurysm-sac-healing-and-prevention-of-expansion-100518370",false,"NCT06029660","AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion","Inclusion Criteria:\n\n1. ≥18 years of age\n2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;\n3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \\\u003C50%, based on pre-procedure CTA\n4. Maximum Lumen diameter within the AAA sac of ≥40mm.\n5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.\n\nExclusion Criteria:\n\nGeneral\n\n1. An inability to provide informed consent.\n2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.\n3. Unable or unwilling to comply with study follow-up requirements.\n4. Prisoner or member of other vulnerable population\n\nAnatomical\n\n1. Concomitant iliac artery ectasia or aneurysm\n2. Vascular disease and\u002For anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.\n3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.\n4. Connective tissue disorder (e.g., Marfan's syndrome)\n5. Aneurysmal disease of the descending thoracic aorta\n6. Excessive calcification at the aortic bifurcation to common\u002Finternal iliac bifurcation, that might lead to access difficulties\n\nEVAR\u002FProcedural\n\n1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA\n2. Use of an aortic stent graft other than those specified1 for a particular site\n3. Planned use of the chosen stent graft outside its instructions for use (IFU)\n4. Use of fenestrated stent grafts or chimney techniques\n5. Use of the Heli-FX EndoAnchor system\n6. Use of embolic devices other than the investigational product to embolize the AAA sac\n7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries\n8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries\n\nMedical History\u002FConditions\n\n1. Coagulopathy or uncontrolled bleeding disorder\n2. Serum creatinine level \\>2.5 mg\u002FdL\n3. Cerebrovascular accident within 3 months prior to the procedure\n4. Myocardial infarction and\u002For major heart surgery within 3 months prior to the procedure\n5. Atrial fibrillation that is not well rate controlled\n6. Life expectancy of \\\u003C2 years post-procedure\n7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.\n8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \\>11,000\u002Fmm3)\n9. A condition that inhibits radiographic visualization during the implantation procedure\n10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.\n11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial\n12. Pregnant or lactating female: for females 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 trial","ALL","18 Years",{"count":18,"type":19},180,"ESTIMATED","INTERVENTIONAL",[22],"NA","To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.",[25],"Aortic Aneurysm, Abdominal",[27],"Abdominal Aortic Aneurysm","RECRUITING","2026-05-02",{"date":31,"type":32},"2026-05-06","ACTUAL",{"date":34,"type":32},"2024-04-05",{"date":36,"type":19},"2031-06",{"name":38,"class":39},"Shape Memory Medical, Inc.","INDUSTRY",49,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100558428","false-lumen-treatment-for-prevention-of-aortic-growth-using-shape-memory-polymer---first-in-human-study-100558428","NCT06550986","False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study","FLAGSHIP_NZL","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 \\>220 µmol\u002FL (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.",{"count":49,"type":19},30,[22],"To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.",[53],"Aortic Dissection","2026-03-19",{"date":56,"type":32},"2026-03-23",{"date":58,"type":32},"2026-02-24",{"date":60,"type":19},"2029-02-15",{"name":38,"class":39},2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":45,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":20,"phases":72,"briefSummary":51,"conditions":73,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100622717","false-lumen-treatment-for-prevention-of-aortic-growth-using-shape-memory-polymer---first-in-human-study-flagshipchl-100622717","NCT07387250","False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)","FLAGSHIP_CHL","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.",{"count":71,"type":19},15,[22],[53],"NOT_YET_RECRUITING","2026-03-17",{"date":54,"type":32},{"date":78,"type":19},"2026-04-01",{"date":80,"type":19},"2029-04-01",{"name":38,"class":39},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":45,"acronym":87,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100573011","false-lumen-treatment-for-prevention-of-aortic-growth-using-shape-memory-polymer---first-in-human-study-flagshipfra-100573011","NCT06740721","False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)","FLAGSHIP_FRA",{"count":71,"type":19},[22],"To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.",[53],"2026-01-27",{"date":94,"type":32},"2026-01-29",{"date":96,"type":19},"2026-10-01",{"date":98,"type":19},"2029-01-03",{"name":38,"class":39},""]