Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT06385067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure rate (TLF)', 'timeFrame': '12 months after surgery', 'description': 'Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)'}], 'secondaryOutcomes': [{'measure': 'Interventional success rate', 'timeFrame': 'Immediately after operation', 'description': 'Including device success rate, pathogenic power and clinical success rate'}, {'measure': 'Device-related cardiovascular clinical composite endpoint', 'timeFrame': 'From postoperative to before discharge, day 30, month 6, month 12, month 24', 'description': 'Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)'}, {'measure': 'Patient-related cardiovascular clinical composite endpoint', 'timeFrame': 'From postoperative to before discharge, day 30, month 6, month 12, month 24', 'description': 'Patient-related cardiovascular clinical composite endpoints including all-cause mortality, all myocardial infarction, and any revascularization (excluding elective interventional therapy) from postoperative to pre-discharge, day 30, month 6, month 12, and month 24'}, {'measure': 'Major adverse cardiac events (MACEs)', 'timeFrame': 'From postoperative to before discharge, day 30, month 6, month 12, month 24', 'description': 'Including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at postoperative to pre-discharge, day 30, month 6, month 12, and month 24.'}, {'measure': 'Incidence of thrombotic events as defined by ARC', 'timeFrame': 'From postoperative to before discharge, day 30, month 6, month 12, month 24', 'description': 'Including identified, probable, and unexcluded thrombosis in the acute, subacute, and late periods acute, subacute, and late Defined, probable, and non-excluded thrombosis within the segment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.\n\nThe study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.', 'detailedDescription': 'Study Design:\n\n1. Prospective, international multi-center clinical study;\n2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;\n3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.\n4. Register and collect data using the EDC system;\n5. Enrollment method: competitive enrollment;\n6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;\n* Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.\n\nExclusion Criteria:\n\n* Pregnant or lactating females;\n* Patients with cardiogenic shock;\n* Patients with severe congestive heart failure or severe heart failure with NYHA class IV;\n* Patients with severe valvular heart disease;\n* Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;\n* Patients who are considered unsuitable for inclusion by the investigator for other reasons.\n* Those who are known to be allergic to melcrolimus and contrast media.'}, 'identificationModule': {'nctId': 'NCT06385067', 'briefTitle': 'Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Medical Systems Ltd'}, 'officialTitle': 'Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World', 'orgStudyIdInfo': {'id': 'JW-PM-DCB-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0 mm-2.75 mm regardless of the number of blood vessels, the length and number of treated lesions.', 'interventionNames': ['Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter']}], 'interventions': [{'name': 'Biolimus Coated Coronary Artery Balloon Dilation Catheter', 'type': 'DEVICE', 'description': 'Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yuanchun Sun', 'role': 'CONTACT', 'email': 'sunyuanchun@bluesail.cn', 'phone': '13683382463'}], 'overallOfficials': [{'name': 'Lang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Guangxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Medical Systems Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}