Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:33 PM
Study NCT ID:
NCT07415902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of Target Lesion Failure (TLF).', 'timeFrame': '24 months', 'description': 'The percentage of subjects who experience TLF from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI), and clinically driven target lesion revascularization (CD-TLR).'}], 'secondaryOutcomes': [{'measure': 'Surgical success rate', 'timeFrame': 'Immediately after the treatment', 'description': 'The percentage of subjects with successful surgery among the total number of subjects. Surgical success is defined as visual residual stenosis diameter ≤30% at the target lesion after PCI, TIMI flow grade 3 (visual assessment), and no rescue stent implantation required.'}, {'measure': 'Incidence of stent thrombosis', 'timeFrame': '24 months', 'description': 'The percentage of subjects with all stent thrombosis events meeting the ARC criteria (including definite and probable) from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects.'}, {'measure': 'Incidence of device-related cardiovascular events (DoCE)', 'timeFrame': '24 months', 'description': 'The percentage of subjects with device-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The device-related clinical composite cardiovascular endpoint is defined as cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.'}, {'measure': 'Incidence of patient-related cardiovascular events (PoCE)', 'timeFrame': '24 months', 'description': 'The percentage of subjects with patient-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The patient-related clinical composite cardiovascular endpoint is defined as all-cause death, all myocardial infarctions, and any repeat revascularization.'}, {'measure': 'Device usage', 'timeFrame': 'Immediately after the treatment', 'description': 'The average number of investigational devices used per lesion and the adjuvant devices used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Drug-Coated Balloon Dilatation Catheter', 'In-Stent Restenosis', 'De Novo Coronary Artery Lesions'], 'conditions': ['In-Stent Restenosis or De Novo Coronary Artery Lesions']}, 'descriptionModule': {'briefSummary': 'This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥18 years old, regardless of gender;\n* Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;\n* Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.\n\nExclusion Criteria:\n\n* Residual stenosis \\>30% after pre-treatment with type C or higher dissection;\n* A history of cardiogenic shock;\n* Severe congestive heart failure or NYHA class IV severe heart failure;\n* Pregnant or lactating women;\n* Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).'}, 'identificationModule': {'nctId': 'NCT07415902', 'briefTitle': 'Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'DK Medical Technology (Suzhou) Co., Ltd.'}, 'officialTitle': 'A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions', 'orgStudyIdInfo': {'id': 'TR-0282'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'treatment group', 'description': 'Coronary Artery Drug-Coated Balloon Dilatation Catheter', 'interventionNames': ['Device: Coronary Artery Drug-Coated Balloon Dilatation Catheter']}], 'interventions': [{'name': 'Coronary Artery Drug-Coated Balloon Dilatation Catheter', 'type': 'DEVICE', 'description': "subjects who have received coronary artery drug-coated balloon dilatation catheter treatment in the selected centers for a period of time since the product's marketing will be screened one by one in accordance with the inclusion and exclusion criteria. During the process, data collection will be conducted by direct medical history collection or reviewing medical records in the medical record system of each center.", 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'min jian tang', 'role': 'CONTACT', 'phone': '+8613525571037'}], 'facility': 'The Second Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'jian min tang, professor', 'role': 'CONTACT', 'email': 'tjmgrx@163.com', 'phone': '+8613525571037'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DK Medical Technology (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}