Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions - Trial NCT06340373
Access comprehensive clinical trial information for NCT06340373 through Pure Global AI's free database. This phase not specified trial is sponsored by National Institute of Cardiovascular Diseases, Bangladesh and is currently Recruiting. The study focuses on Coronary Artery Disease. Target enrollment is 303 participants.
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Study Focus
Sponsor & Location
National Institute of Cardiovascular Diseases, Bangladesh
Timeline & Enrollment
N/A
Jan 01, 2024
Jun 30, 2025
Primary Outcome
CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant,Number of participants with target vessel Myocardial infarction,Ischemia-driven Target lesion revascularization (TLR) each participant,Occurrence of Cardiac death in the participants,Site of the lesion,Lesion Length,% of Stenosis,Thrombolysis in Myocardial Infarction (TIMI) Flow,Pre dilatation - Balloon Type
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06340373
Device Trial