Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02512003
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemia-driven Target Lesion Revascularization (TLR)', 'timeFrame': '4 months', 'description': 'Percent of Patients with TLR at 4 months'}], 'secondaryOutcomes': [{'measure': 'Quantitative Coronary Angiography (QCA) derived parameters', 'timeFrame': '4 months', 'description': 'Late Loss'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters', 'timeFrame': '4 months', 'description': 'Restenosis Rate'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters', 'timeFrame': '4 months', 'description': '% Diameter Stenosis'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters', 'timeFrame': '4 months', 'description': 'Minimum Lumen Diameter'}, {'measure': 'Quantitative Coronary Angiography (QCA) derived parameters', 'timeFrame': '4 months', 'description': 'Neointimal Volume'}, {'measure': 'Intravascular Ultrasound (IVUS) derived parameters', 'timeFrame': '4 months', 'description': 'Late Loss'}, {'measure': 'Intravascular Ultrasound (IVUS) derived parameters', 'timeFrame': '4 months', 'description': 'Restenosis Rate'}, {'measure': 'Intravascular Ultrasound (IVUS) derived parameters', 'timeFrame': '4 months', 'description': '% Diameter Stenosis'}, {'measure': 'Intravascular Ultrasound (IVUS) derived parameters', 'timeFrame': '4 months', 'description': 'Minimum Lumen Diameter'}, {'measure': 'Intravascular Ultrasound (IVUS) derived parameters', 'timeFrame': '4 months', 'description': 'Neointimal Volume'}, {'measure': 'Major Adverse Cardiac Events', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB \\> 5x normal), Target Vessel Revascularization'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TLR at each time point'}, {'measure': 'Target Vessel Revascularization', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TVR at each time point'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '12, 24, 36, 48 and 60 months', 'description': 'Percentage of patients with TVF at each time point'}, {'measure': 'Acute Technical Success', 'timeFrame': 'Day 0', 'description': 'Percentage of patients with successful acute delivery and deployment of the device'}, {'measure': 'Procedural Success', 'timeFrame': '30 days', 'description': 'Percentage of patients with angiographic success (final diameter stenosis \\<50% without occurrence of MACE)'}, {'measure': 'Optical Coherence Tomography (OCT) Imaging on a Subset of Patients', 'timeFrame': '4 months', 'description': 'Qualitative measures in a subset of patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The FANTOM I pilot study is intended to assess safety 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* Patient has a normal CK-MB\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 ≥ 2.7mm and ≤ 3.3mm\n* Target lesion length must be ≤ 14mm\n\nExclusion Criteria:\n\n* Patient has experienced a myocardial infarction (CK-MB or Troponin \\> 5 X ULN) within 72 hours of the procedure\n* Patient has a left ventricular ejection fraction \\< 25%\n* Patient has unprotected lest 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 ≥ 2.0 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': 'NCT02512003', 'acronym': 'FANTOM I', 'briefTitle': 'Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)', 'organization': {'class': 'INDUSTRY', 'fullName': 'REVA Medical, Inc.'}, 'officialTitle': 'Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold', 'orgStudyIdInfo': {'id': 'HCT6000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fantom Treatment group', 'interventionNames': ['Device: Fantom Scaffold']}], 'interventions': [{'name': 'Fantom Scaffold', 'type': 'DEVICE', 'armGroupLabels': ['Fantom Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'REVA Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}