Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 6:41 AM
Study NCT ID:
NCT06212193
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2023-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Observational endpoint', 'timeFrame': 'at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years', 'description': 'All-cause mortality'}], 'primaryOutcomes': [{'measure': 'Rate of Major Adverse Events [Safety endpoint]', 'timeFrame': 'at the end of the procedure, at discharge - typically within a week, and 30 days', 'description': 'Rate of device or procedure-related Major Adverse Events (MAEs)\n\nAnd\n\nRate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure'}, {'measure': 'Technical Performance', 'timeFrame': 'at the end of the procedure, at discharge - typically within a week, and 30 days', 'description': 'Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \\[at the end of the procedure\\]\n\nAnd\n\nNo need for re-intervention due to device valve regurgitation or para-stent leak \\[at discharge, and 30 days\\]'}], 'secondaryOutcomes': [{'measure': 'Rate of Major Adverse Events [Safety endpoint]', 'timeFrame': 'at 3 months, 6 months, 1, 2, 3, 4, and 5 years', 'description': '* Composite of all device or procedure-related MAEs \\[at 3 months, 6 months, 1, 2, 3, 4, and 5 years\\].\n* Device thrombosis, evaluated by Echocardiography \\[at 30 days, 6 months, 1, 2, and 4 years\\].\n* Device Migration as evaluated by Echocardiography or CMR \\[at 6 months\\]'}, {'measure': 'Efficacy endpoint', 'timeFrame': 'at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year', 'description': 'One or more of the following-\n\n* TR grade as measured on the device valves by Echocardiography, or reduction in peak CVP as measured by right heart catheterization \\[at the end of the procedure\\]\n* TR grade as measured on the device valves by Echocardiography \\[at 30 days, 6-month, 1-year, 2-year, and 4-year\\]\n* Rate of hospitalizations for HF \\[at 6-month, and 1-year\\]\n* HF functional class (NYHA) \\[at 30 days, 3-month, 6-month,1-year, 2-year, 3-year, 4-year, and 5-year\\]\n* Six-minute walk test (6MWT) \\[at 30 days, 6-month, 1-year, 2-year, and 4-year\\]\n* The Kansas City Cardiomyopathy Questionnaire (KCCQ) \\[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\\]\n* Patient Global Assessment (PGA) for Tricuspid Regurgitation Valve Treatment \\[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tricuspid valve', 'Transcatheter', 'Tricuspid Regurgitation', 'Tricuspid valve insufficiency'], 'conditions': ['Tricuspid Regurgitation', 'Tricuspid Regurgitation Functional']}, 'descriptionModule': {'briefSummary': 'Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).', 'detailedDescription': 'Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).\n\nUp to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has clinically significant TR graded as severe or greater\n* Peak central venous pressure of ≥ 15mmHg\n* Patient has NYHA functional classification of III or IV\n* Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic\n\nExclusion Criteria:\n\nPatients will be excluded from participation if ANY of the following criteria apply:\n\n* Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.\n* Anatomical suitability according to CT scan.\n* Systolic Pulmonary Artery Pressure \\> 65mmHg\n* Moderate or more mitral valve stenosis\n* Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation\n* Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation\n* Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \\< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis\n* Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)\n* Thrombocytopenia (Platelet count\\< 80,000/mm3) or thrombocytosis (Platelet count \\> 750,000/mm3) within 14 days of the index procedure\n* In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \\< 12 months"}, 'identificationModule': {'nctId': 'NCT06212193', 'briefTitle': 'Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innoventric LTD'}, 'officialTitle': 'Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)', 'orgStudyIdInfo': {'id': 'CLD-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Innoventric Trillium™ Stent Graft', 'description': 'Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft', 'interventionNames': ['Device: Trillium™']}], 'interventions': [{'name': 'Trillium™', 'type': 'DEVICE', 'description': 'Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement', 'armGroupLabels': ['Innoventric Trillium™ Stent Graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mane Arabyan', 'role': 'CONTACT', 'email': 'Mane.Arabyan@HCAHealthcare.com', 'phone': '8057963746'}, {'name': 'Saibal Kar, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovascular Institute of Los Robles Health System', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Bess', 'role': 'CONTACT', 'email': 'renee.bess@ascension.org', 'phone': '313.343.4811'}, {'name': 'Amir Kaki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascension St. John', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mattie Reesman', 'role': 'CONTACT', 'email': 'Reesman.Margaret@mayo.edu'}, {'name': 'Mackram F Eleid', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital (Rochester)', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rose Spuhler', 'role': 'CONTACT', 'email': 'ros4026@med.cornell.edu'}, {'name': 'Mark Reisman, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ruth J Tenzler Stein', 'role': 'CONTACT', 'email': 'Ruth.Stein@stonybrookmedicine.edu'}, {'name': 'Ahmad AlKhalil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook Heart Institute', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katy Fischesser', 'role': 'CONTACT', 'email': 'Katy.Fischesser@thechristhospital.com', 'phone': '513-585-1932'}, {'name': 'Santiago Garcia, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19096', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tisha Farinha', 'role': 'CONTACT', 'email': 'FarinhaT@MLHS.ORG', 'phone': '484.476.8580'}, {'name': 'William Gray', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lankenau Heart Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bentley Abby', 'role': 'CONTACT', 'email': 'Abigail.Bentley@HCAhealthcare.com'}, {'name': 'Samuel Horr, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TriStar Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Tushinski', 'role': 'CONTACT', 'email': 'jtushin@uw.edu'}, {'name': 'James M McCabe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kim Laura Suder', 'role': 'CONTACT', 'email': 'Studienzentrum-ZfK@unimedizin-mainz.de', 'phone': '06131 17 6794'}, {'name': 'Karl Patrik Kresoja, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medicine Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jospehin Kister', 'role': 'CONTACT', 'email': 'Jospehin.Kister@helios-health-insitute.com', 'phone': '0341 865 251551'}, {'name': 'Tobias Kister, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helios Health Institute GmbH, Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Haley Hartmann', 'role': 'CONTACT', 'email': 'haley.hartmann@dhzc-charite.de', 'phone': '030 450 665 474'}, {'name': 'Tobias Daniel Trippel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'German Heart Center at Charité (DHZC)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Chen Lereya', 'role': 'CONTACT', 'email': 'chen@innoventric.com', 'phone': '+972-52-8981783'}, {'name': 'Amir Danino', 'role': 'CONTACT', 'email': 'amir@innoventric.com', 'phone': '+972-54-7256930'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innoventric LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Innoventric Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}