Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 6:00 PM
Study NCT ID:
NCT02539966
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2015-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events (MACE) - Cohorts A, B and C', 'timeFrame': '6 months', 'description': 'Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB \\>5X ULN) (MI), and target lesion revascularization (TLR)'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C', 'timeFrame': '6 months', 'description': 'Late Lumen Loss'}], 'secondaryOutcomes': [{'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohort B', 'timeFrame': '9 months', 'description': 'Late Lumen Loss'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C', 'timeFrame': '6 months', 'description': 'Minimum Lumen Diameter (MLD)'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohort B', 'timeFrame': '9 months', 'description': 'Minimum Lumen Diameter (MLD)'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C', 'timeFrame': '6 months', 'description': '% Diameter Stenosis'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohort B', 'timeFrame': '9 months', 'description': '% Diameter Stenosis'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C', 'timeFrame': '6 months', 'description': 'Binary Restenosis'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters - Cohort B', 'timeFrame': '9 months', 'description': 'Binary Restenosis'}, {'measure': 'Major Adverse Cardiac Events (MACE) - Cohorts A, B and C', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB \\>5X ULN) (MI), and target lesion revascularization (TLR)'}, {'measure': 'Target Lesion Revascularization (TLR) - Cohorts A, B and C', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TLR at each time point'}, {'measure': 'Target Vessel Revascularization (TVR) - Cohorts A, B and C', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TVR at each time point'}, {'measure': 'Target Vessel Failure (TVF) - Cohorts A, B and C', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TVF at each time point'}, {'measure': 'Acute Technical Success - Cohorts A, B and C', 'timeFrame': 'Day 0', 'description': 'Successful acute delivery and deployment of the device'}, {'measure': 'Procedural Success - Cohorts A, B and C', 'timeFrame': '30 days', 'description': 'Percentage of patients with angiographic success (final diameter stenosis \\<50% without occurrence of MACE)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '31177821', 'type': 'DERIVED', 'citation': 'Chevalier B, Abizaid A, Carrie D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has evidence of myocardial ischemia or a positive functional study\n* Target lesion has a visually estimated stenosis of ≥50% and \\<100%\n* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm\n* Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)\n* Baseline TIMI flow ≥ 2\n\nExclusion Criteria:\n\n* The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.\n* Patient has a left ventricular ejection fraction \\< 40%\n* Patient has unprotected left main coronary disease with ≥50% stenosis\n* The target vessel is totally occluded (TIMI Flow 0 or 1)\n* Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).\n* Target lesion is located within a bypass graft\n* Target lesion has possible or definite thrombus'}, 'identificationModule': {'nctId': 'NCT02539966', 'acronym': 'FANTOM II', 'briefTitle': 'Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold', 'organization': {'class': 'INDUSTRY', 'fullName': 'REVA Medical, Inc.'}, 'officialTitle': 'Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold', 'orgStudyIdInfo': {'id': 'HCT6200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'description': 'Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)', 'interventionNames': ['Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B', 'description': 'Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)', 'interventionNames': ['Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C', 'description': 'Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel', 'interventionNames': ['Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold']}], 'interventions': [{'name': 'Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold', 'type': 'DEVICE', 'description': 'Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chermside', 'country': 'Australia', 'facility': 'The Prince Charles Hospital', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'city': 'Darlinghurst', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Randwick', 'country': 'Australia', 'facility': 'Prince of Wales Hospital (Eastern Heart)', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Cardiovascular Center Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Albert Einstein Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital (Skejby)', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Massy', 'country': 'France', 'facility': 'institut Hospitalier J.Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'city': 'Paris', 'country': 'France', 'facility': 'La Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Am Urban Hospital, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Friedrichshein Hospital, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'St.- Johannes-Hospital Dortmund', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowskie Centrum Kardiologii Inwazyjnej', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Oddział Kardiologii Inwazyjnej I Katedra', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Alexandre Abizaid, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese de Cardiologia'}, {'name': 'Christoph K Naber, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elisabeth-Krankenhaus Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'REVA Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}