protocolSection identificationModule nctId: NCT06340373, orgStudyIdInfo id: NICVD/ 2023/ 32, secondaryIdInfos id: NICVD /Ethical/ 2023/ 32, type: OTHER, domain: National Institute of Cardiovascular Diseases(NICVD), briefTitle: Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Institute of Cardiovascular Diseases, Bangladesh, class: OTHER, descriptionModule briefSummary: The progression of cardiac revascularization techniques, starting with standard balloon angioplasty (POBA) and progressing to the creation of drug-coated balloons (DCB) and drug-eluting stents (DES). The study's justification is presented, with a focus on the significance of comprehending the clinical and angiographic outcomes of DCB angioplasty, especially when considering the Bangladeshi population.This study's main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized. A few specific goals are to evaluate angiographic results (like percentage diameter stenosis, vascular remodelling, restenosis, and thrombosis) after DCB angioplasty and to assess clinical outcomes (like worsening angina, target vessel MI, ischemia-driven TLR, and cardiac mortality).This observational study will take place from January to December 2024 at the Department of Cardiology, National Institute of Cardiovascular Diseases. The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before. The study includes non-randomized purposive sampling, and the sample size will be determined by drawing on previous studies.Every patient will receive a thorough clinical assessment that includes a history, physical examination, electrocardiogram, and biochemical testing. The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography.The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions, including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 303, type: ESTIMATED, armsInterventionsModule interventions name: DCB Angioplasty, outcomesModule primaryOutcomes measure: CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant, primaryOutcomes measure: Number of participants with target vessel Myocardial infarction, primaryOutcomes measure: Ischemia-driven Target lesion revascularization (TLR) each participant, primaryOutcomes measure: Occurrence of Cardiac death in the participants, primaryOutcomes measure: Site of the lesion, primaryOutcomes measure: Lesion Length, primaryOutcomes measure: % of Stenosis, primaryOutcomes measure: Thrombolysis in Myocardial Infarction (TIMI) Flow, primaryOutcomes measure: Pre dilatation - Balloon Type, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of CardioVascular Diseases, status: RECRUITING, city: Dhaka, zip: 1207, country: Bangladesh, contacts name: Sayeedur Rahman Khan, MD, role: CONTACT, phone: +8801711850078, email: dr.rumibd@gmail.com, contacts name: Md Zahid Hasan, MD, role: CONTACT, phone: +8801723-218955, email: zhasan390@gmail.com, contacts name: Prof. Mohsin Ahmed, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Sayeedur Rahman Khan, MD, role: SUB_INVESTIGATOR, contacts name: Dr. Md Zahid Hasan, MD, role: SUB_INVESTIGATOR, contacts name: Dr. Shariful Islam, MD, role: SUB_INVESTIGATOR, contacts name: Dr. CM Kudrat E Khuda, MD, role: SUB_INVESTIGATOR, contacts name: Dr. Mohammad Arifur Rahman, MD, role: SUB_INVESTIGATOR, contacts name: Dr. Md Matiur Rahman, MD, role: SUB_INVESTIGATOR, contacts name: Dr. SA Shiblee, MPH, role: SUB_INVESTIGATOR, contacts name: Md. Habibur Rahman, M.Sc, role: SUB_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False