Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-07 @ 12:14 AM
Study NCT ID:
NCT06620458
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-09-28', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '12 months', 'description': 'cardiovascular adverse events:defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)).'}], 'secondaryOutcomes': [{'measure': 'LLL(late lumen loss)', 'timeFrame': '12 months', 'description': 'Detection by QCA technique by subtracting the minimum lumen diameter at review from the minimum lumen diameter in the immediate postoperative period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DCB CHD IVUS OCT'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.', 'detailedDescription': 'This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. The study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). It primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(Including OCT, IVUS), hemodynamic parameter，and procedural approaches among patients. Over 5000 patients are expected to be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study targets adults aged 18 and over who have been diagnosed with coronary artery disease featuring native large vessel lesions and are scheduled to undergo paclitaxel drug-coated balloon angioplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:\n\n 18 years and older.\n* Diagnosis:\n\nDiagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.\n\n* Treatment Plan:\n\nScheduled to receive paclitaxel drug-coated balloon angioplasty.\n\n* Informed Consent:\n\nPatients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.\n\n* Physiological Status:\n\nCardiac function classified as NYHA I-III.\n\nExclusion Criteria:\n\n* Allergy History:\n\nKnown allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).\n\n* Severe Complications:\n\nUncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg).\n\n* Other Medical Conditions:\n\nActive bleeding or clotting disorders.\n\n* Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer).\n* Pregnancy or Nursing: Women who are currently pregnant or breastfeeding.\n* Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study.\n* Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.'}, 'identificationModule': {'nctId': 'NCT06620458', 'acronym': 'RE-DCB', 'briefTitle': 'A Retrospective Study on the Factors of Drug-coated Balloon Restenosis', 'organization': {'class': 'OTHER', 'fullName': 'Henan Institute of Cardiovascular Epidemiology'}, 'officialTitle': 'A Retrospective Study on the Factors of Drug-coated Balloon Restenosis', 'orgStudyIdInfo': {'id': 'HenanICE202403'}}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quan Guo', 'role': 'CONTACT', 'email': 'xinyiguoquan@163.com', 'phone': '15670510031'}], 'facility': 'Fuwai Central China Cardiovascular Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Quan Guo, MD', 'role': 'CONTACT', 'email': 'xinyiguoquan@163.com', 'phone': '+8615670510031'}], 'overallOfficials': [{'name': 'Muwei Li, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai central China cardiovascular hospotial'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Institute of Cardiovascular Epidemiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}