Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-28 @ 10:54 AM
Study NCT ID:
NCT04565561
Status:
UNKNOWN
Last Update Posted:
2020-09-25
First Post:
2020-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late lumen loss (LLL)', 'timeFrame': '1-year', 'description': 'The primary endpoint in-segment is late lumen loss (LLL) with follow-up of 1 year.'}], 'secondaryOutcomes': [{'measure': 'target lesion revascularization (TLR)', 'timeFrame': '1-year', 'description': 'The secondary endpoint is target lesion revascularization (TLR) with follow-up of 1 year.'}, {'measure': 'cardiac death', 'timeFrame': '1-year', 'description': 'The secondary endpoint is cardiac death with follow-up of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neovas BRS', 'DCB', 'DES', 'STEMI'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'a prospective, single center, observational clinical trail. Aim to to compare the efficacy and safety of the Bioabsorbable scaffold (BRS) Neovas BRS and Drug-coating balloon (DCB) in the treatment of STEMI patients with coronary artery disease and to further evaluate the safety and effectiveness of the two new interventional methods in STEMI intervention, so as to better guide clinical practice.', 'detailedDescription': '1. To study the advantages and disadvantages of Neovas BRS and DCB in interventional treatment of de novo lesions in STEMI patients, in order to better guide the clinical.\n2. To explore the safety of Neovas BRS in interventional treatment of ide novo lesions in STEMI patients.\n3. To explore the safety of DCB in interventional treatment of de novo lesions in STEMI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'STEMI patients undergoing PPCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Age \\> 18 years old (2) STEMI patients suitable for PPCI operation. Chest pain for more than 20 minutes; At least 2 leads ST-T segment elevation \\> 1 mm, or new LBBB, or myocardial infarction confirmed by echocardiography; It is expected that the reperfusion treatment can be successfully implemented within 12 hours after the occurrence of acute myocardial infarction.\n\n(3) Target vessels are suitable for PPCI and Single vessel disease (non culprit vessel stenosis \\< 50%). It is a primary coronary lesion; Reference vessel diameter \\> 2.5mm and \\< 4mm, lesion length \\< 20mm; There is no obvious calcification at the lesion site; After thrombus aspiration or pre dilation balloon pretreatment, the residual stenosis \\< 30% has no blood flow restrictive dissection.\n\n(4) Patients refused to accept drug-eluting stent implantation, voluntarily participated and signed informed consent, accepted and was willing to cooperate with follow-up, and was willing to cooperate with standard secondary prevention and treatment of coronary heart disease.\n\nExclusion Criteria:\n\nThe age is less than 18 years old; Previous history of myocardial infarction or post coronary stent operation; Left main disease; It is known that it is contraindications or resistance to the following drugs: bevaludine, low molecular heparin, common heparin, aspirin, clopidogrel / tegrelol; Participate in other clinical studies and interfere with the study; It is uncertain whether there is any neurological injury: for example, after resuscitation; It needs tracheal intubation / artificial ventilation; There was cardiogenic shock before grouping; It is known that there are intracranial diseases: occupying position, aneurysm, arteriovenous malformation, hemorrhagic cerebrovascular accident, ischemic cerebrovascular accident; Internal bleeding such as gastrointestinal bleeding before selection; It is planned to perform major surgical treatment within 6 weeks; Serious infectious disease, malignant tumor disease, serious blood disease and autoimmune disease; in recent March, there has been a history of large-dose use of immunosuppressant; Non coronary vasculitis and thrombotic diseases (vasculitis, aortic dissection, abdominal aneurysm); Serious mental illness patients; The life expectancy is less than 1 year; No consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04565561', 'acronym': 'NeovasvsDCB', 'briefTitle': 'Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen People's Hospital"}, 'officialTitle': 'Neovas Versus DCB for Coronary de Novo Lesions in Patients With STEMI: a Prospective Observational Clinical Trial', 'orgStudyIdInfo': {'id': 'KY-LL-2020099-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neovas BRS group', 'description': 'Neovas BRS group, n=20', 'interventionNames': ['Device: Neovas BRS or DCB']}, {'label': 'DCB group', 'description': 'DCB group, n=20', 'interventionNames': ['Device: Neovas BRS or DCB']}], 'interventions': [{'name': 'Neovas BRS or DCB', 'type': 'DEVICE', 'otherNames': ['DES'], 'description': 'All STEMI patients were predilated (including predilated balloon or cutting balloon) before randomization. Thrombus aspiration was determined by the surgeon according to the specific situation.\n\nSufficient predilation criteria: the following two conditions must be met: A. residual stenosis \\< 30%; B. no flow limiting dissection or TIMI grade 2-3.', 'armGroupLabels': ['DCB group', 'Neovas BRS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yaowang lin, Master', 'role': 'CONTACT', 'email': 'linyw012@hotmail.com', 'phone': '+86-20-22943200'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'yaowang lin, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shenzhen People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}