Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-03 @ 12:35 PM
Study NCT ID:
NCT02688868
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhanght@microport.com', 'phone': '+862138954600', 'title': 'HT Zhang', 'phoneExt': '8552', 'organization': 'Shanghai Microport Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 32, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'elevated myocardial enzyme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'No-reflow phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intermediate lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Repeat chest & back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal liver function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical spondylopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'soft tissue disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'perioperation hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'perioperation slow heart beat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleeping disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicosity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rapid heart beat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'unsatifactory blood glucose control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lumbago', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deaf', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'disc herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'target lesion revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'in-stent restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rehospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'non target lesion revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal artery implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death of cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'In-stent Late Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 month after stent implantation', 'description': 'the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One missed participant in 3 years follow up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two missed participant in 4 years follow up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One missed participant in 3 years follow up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One missed participant in 3 years follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'New Specifications (Diameter 2.25mm)of Firehawk Stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease\n\nFirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.22', 'spread': '9.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2016-02-18', 'resultsFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-09', 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-stent Late Loss', 'timeFrame': '9 month after stent implantation', 'description': 'the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Target Lesion Failure', 'timeFrame': '12 months', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization'}, {'measure': 'Number of Participants With Target Lesion Failure', 'timeFrame': '2 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization'}, {'measure': 'Number of Participants With Target Lesion Failure', 'timeFrame': '3 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization'}, {'measure': 'Number of Participants With Target Lesion Failure', 'timeFrame': '4 years', 'description': 'including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization'}, {'measure': 'Number of Participants With MACE', 'timeFrame': '12 months', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization'}, {'measure': 'Number of Participants With MACE', 'timeFrame': '2 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization'}, {'measure': 'Number of Participants With MACE', 'timeFrame': '3 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization'}, {'measure': 'Number of Participants With MACE', 'timeFrame': '4 years', 'description': 'a composite endpoint of all cause death, any myocardial infarction and any revascularization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-80 years of age, males or non-pregnant women;\n2. Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;\n3. Primary target lesion, in situ coronary artery disease;\n4. Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);\n5. The target lesion diameter stenosis ≥ 70% (Visual method);\n6. Each target lesion implantation the same stent (Firehawk stent);\n7. With indications for coronary artery bypass surgery;\n8. To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.\n\nExclusion Criteria:\n\n1. Within 72h of any acute myocardial infarction;\n2. Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;\n3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;\n4. Artery and/or vein bypass graft lesions;\n5. Intracoronary implantation of any branding stents within 1 year;\n6. Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction \\<35% (ultrasound or left ventricular angiography);\n7. Preoperative renal function serum creatinine \\>2.0mg/DL;\n8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;\n9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;\n10. The patient's life expectancy is less than 12 months;\n11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;\n12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;\n13. Heart transplantation patients."}, 'identificationModule': {'nctId': 'NCT02688868', 'briefTitle': 'Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai MicroPort Medical (Group) Co., Ltd.'}, 'officialTitle': 'The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.', 'orgStudyIdInfo': {'id': 'Firehawk_SS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'new specifications (Diameter 2.25mm)of Firehawk stent', 'description': 'Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease', 'interventionNames': ['Device: FirehawkTM 2.25mm']}], 'interventions': [{'name': 'FirehawkTM 2.25mm', 'type': 'DEVICE', 'description': 'Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems', 'armGroupLabels': ['new specifications (Diameter 2.25mm)of Firehawk stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fu Wai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Runlin Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Wai Hospital & National Center for Cardiovascular Diseases in China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai MicroPort Medical (Group) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}