Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT04704258
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2021-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events', 'timeFrame': '30 days', 'description': 'Primary Safety Endpoint: FLOWer device Safety, rate of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. MACCEs are based on the Valve Academic Research Consortium (VARC- 3) criteria:\n\n* all death;\n* all stroke (disabling and non-disabling);\n* acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first)'}, {'measure': 'Reduction in total volume of new cerebral lesions in all territories at serial DWMRI', 'timeFrame': 'Within 2-5 days after procedure vs. baseline', 'description': 'Primary Clinical Benefit Endpoint: Reduction in total volume of new cerebral lesions in all territories at serial DWMRI, compared to historical data in control arm (unprotected) data from previous randomized studies'}], 'secondaryOutcomes': [{'measure': 'Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee.', 'timeFrame': '7 and 30 days', 'description': 'Secondary Safety Endpoint: Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. all-cause mortality including cardiovascular mortality;\n\n* all stroke (disabling and non-disabling);\n* bleeding (life-threatening or disabling);\n* acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first);\n* major device access related vascular complications;\n* coronary artery obstruction requiring intervention;\n* valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, repeat TAVI, or surgical aortic valve replacement).'}, {'measure': 'Brain imaging (DW-MRI)', 'timeFrame': 'Within 2-5 days after procedure vs. baseline', 'description': 'Secondary Clinical Benefit Endpoints: Acute cerebral embolic burden reduction after TAVI, defined as number and volume of new cerebral lesions in all cerebral territories assessed by DW-MRI'}, {'measure': 'Neurocognitive', 'timeFrame': '2-7 days and 30-days vs. baseline', 'description': 'Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS'}, {'measure': 'Technical Success', 'timeFrame': 'Immediately after procedure', 'description': 'Secondary Performance Endpoints: Technical Success defined as successful placement, insertion and removal of the FLOWer System'}, {'measure': 'Debris capture', 'timeFrame': 'Immediately after procedure', 'description': 'Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition'}, {'measure': 'FLOWer System Usability', 'timeFrame': 'Immediately after procedure', 'description': 'Secondary Performance Endpoints: FLOWer System Usability graded by the Investigator with a 5-point Likert scale\n\nThe minimum and the maximum values of the scale are defined as follows:\n\n(1) Unacceptable; (2) Poor; (3) Acceptable; (4) Good; (5) Excellent'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVI', 'Transcatheter Anti-embolic Filter', 'Cerebral Embolic Protection', 'Embolic Protection Device', 'Debris', 'Embolic material'], 'conditions': ['Aortic Valve Stenosis', 'Intracranial Embolism and Thrombosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aorticlab.ch', 'label': 'Aorticlab Sponsor website'}, {'url': 'http://www.meditrial.net', 'label': 'Meditrial Clinical Research Organization'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic Valve Implant).', 'detailedDescription': 'A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of age ≥ 18 years\n2. Subject is scheduled to undergo transfemoral aortic valve implant (TAVI) procedure on a stenotic native aortic valve and is qualified based on pre-operative CT-scan examination (trans-thoracic echocardiogram (TTE) can be used as confirmatory assessment)\n3. Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size\n4. The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits\n5. The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB)\n\nExclusion Criteria:\n\nClinical exclusion criteria (preoperative screening)\n\n1. Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin\n2. Subjects with contraindication to cerebral MRI\n3. Subjects with a history of a stroke or transient ischemic attack within the prior 6 months\n4. Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure\n5. Renal insufficiency (creatinine \\> 3.0 mg/dL or Glomerular Filtration Rate GFR \\< 30) and/or renal replacement therapy at the time of screening\n6. Subjects with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months\n7. Subjects with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated\n8. Subject is currently participating in another drug or device clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation\n9. Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI)\n10. Subject requires an emergent procedure\n11. Subject has active major psychiatric disease\n12. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities\n13. Subject has an ejection fraction of 30% or less\n14. Subjects with active endocarditis or other systemic infection\n15. Subjects undergoing therapeutic thrombolysis\n16. Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test\n\nComputerized Tomographic exclusion criteria (preoperative screening)\n\n1. Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch\n2. Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation\n3. Subjects with a diameter of the ascending aorta \\< 25 and \\> 39 mm at baseline CT (measured 10 mm upstream of the first vessel of the brachiocephalic trunk)\n4. Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route\n5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access\n6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous'}, 'identificationModule': {'nctId': 'NCT04704258', 'acronym': 'NAUTILUS', 'briefTitle': 'NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'AorticLab Srl'}, 'officialTitle': 'Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions', 'orgStudyIdInfo': {'id': '#2020-01 (EU)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAVI + Embolic protection', 'description': 'Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI', 'interventionNames': ['Procedure: TAVI (Transcatheter Aortic Valve Implant)', 'Device: FLOWer Embolic Protection System']}], 'interventions': [{'name': 'TAVI (Transcatheter Aortic Valve Implant)', 'type': 'PROCEDURE', 'description': 'Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures', 'armGroupLabels': ['TAVI + Embolic protection']}, {'name': 'FLOWer Embolic Protection System', 'type': 'DEVICE', 'otherNames': ['transcatheter embolic protection for TAVI procedures'], 'description': 'FLOWer Embolic Protection System', 'armGroupLabels': ['TAVI + Embolic protection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CUB Hôpital Erasme (ULB)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '20900', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'facility': 'Casa di Cura Policlinico di Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'MI', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '85100', 'city': 'Potenza', 'state': 'PZ', 'country': 'Italy', 'facility': 'San Carlo Azienda Ospedaliera Regionale', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Clinica San Gaudenzio', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Franco Osta', 'role': 'STUDY_CHAIR', 'affiliation': 'AorticLab Srl'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AorticLab Srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}