Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:41 AM
Study NCT ID:
NCT07387250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Immediately after the intervention', 'description': 'Delivery and implantation of the investigational product implant to the false lumen'}, {'measure': 'Major adverse events', 'timeFrame': '30 days', 'description': 'Incidence of device/procedure-related major adverse events'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality and dissection-related mortality', 'timeFrame': '2 years', 'description': 'Incidence of all-cause mortality and dissection-related mortality'}, {'measure': 'Serious adverse events', 'timeFrame': '2 years', 'description': 'Incidence of device/procedure-related serious adverse events'}, {'measure': 'Change in false lumen thrombosis from baseline', 'timeFrame': '2 years', 'description': 'Change in false lumen thrombosis from baseline'}, {'measure': 'Change in true lumen/aorta size ratio from baseline', 'timeFrame': '2 years', 'description': 'Change in true lumen/aorta size ratio from baseline'}, {'measure': 'Change in aorta size from baseline', 'timeFrame': '2 years', 'description': 'Change in aorta size from baseline'}, {'measure': 'Rate of dissection-related reinterventions', 'timeFrame': '2 years', 'description': 'Rate of dissection-related reinterventions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/TL treatment, OR\n* A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL 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 (\\<15 days from symptom onset).\n* Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).\n* Vascular disease, aortic rupture, and/or anatomy and/or 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/or TL.\n* Absence of/inability to create a reentry tear/fenestration 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/dL (within 90 days prior to the procedure).\n* Cerebrovascular accident within 90 days prior to the procedure.\n* Myocardial infarction and/or 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 \\<2 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."}, 'identificationModule': {'nctId': 'NCT07387250', 'acronym': 'FLAGSHIP_CHL', 'briefTitle': 'False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shape Memory Medical, Inc.'}, 'officialTitle': 'False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study', 'orgStudyIdInfo': {'id': 'CRD1063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention', 'description': 'Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill', 'interventionNames': ['Device: False Lumen Embolization System, IMPEDE-FX RapidFill']}], 'interventions': [{'name': 'False Lumen Embolization System, IMPEDE-FX RapidFill', 'type': 'DEVICE', 'description': 'Embolization of the false lumen of an aortic dissection', 'armGroupLabels': ['Experimental: Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shape Memory Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}