Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
- Conditions
- Coronary Artery Disease
- Interventions
- Device: DCB Angioplasty
- Registration Number
- NCT06340373
- Lead Sponsor
- National Institute of Cardiovascular Diseases, Bangladesh
- Brief 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.
- Detailed Description
In recent years, drug-coated balloon (DCB) therapy has been rapidly accepted in clinical practice, especially for the treatment of in-stent restenosis. More recently, the use of DCB is spreading to de novo CAD. The DCB has beneficial features, such as allowing local drug delivery without the need to implant any metal. Subsequently, the duration of dual antiplatelet therapy (DAPT) is shortened. Importantly, the DCB is just a delivery vehicle, and does not assist in dilating narrowed coronary vessels. Thus, lesion preparation with standard balloon angioplasty is the key to successful DCB treatment, and is essential before the use of a DCB. The aim of effective lesion preparation is to gain sufficient luminal enlargement, while minimizing coronary dissection. As DCBs are fulfilling the concept of "leaving nothing behind" and guidelines are also recommended as class I indication the use of DCBs have become an alternative therapeutic option for the treatment of ISR \& small de novo vessel. Till to date no such type of study conducted in Bangladesh. That's why the investigators designed this study with the aim to observe clinical and angiographic outcomes of drug-coated balloon angioplasty after successful revascularization of native coronary lesions among Bangladeshi population which is very essential and relevant in the context of Bangladesh.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 303
- Patients with successful revascularization of native coronary lesions (diameter >2.0 mm and ≦3.5 mm at visual estimation) six months back by drug-coated balloon angioplasty.
- Informed consent to participate in the study
- Creatinine clearance <30 ml/min
- Left ventricular ejection fraction <30%
- Life expectancy <12 months
- Target lesion/vessel with any of the following characteristics: - concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery)
- Previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery)
- Patient who will not give consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with native coronary lesions (2.0-3.5 mm diameter) after drug-coated balloon angioplasty DCB Angioplasty Patients with successful revascularization of native coronary lesions (diameter \>2.0 mm and ≦3.5 mm at visual estimation) by drug-coated balloon angioplasty and follow up after six month by coronary angiography
- Primary Outcome Measures
Name Time Method Ischemia-driven Target lesion revascularization (TLR) each participant Six months The need for repeat intervention (such as another angioplasty or stent placement) in the same artery that was initially treated with the drug-coated balloon.
Site of the lesion Six months Vessel \& Location
CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant Six months Exacerbation of chest pain symptoms following the procedure, possibly indicating complications or inadequate treatment effectiveness.
Number of participants with target vessel Myocardial infarction Six months Potential damage to the heart muscle due to reduced blood flow in the treated vessel, possibly resulting from a clot or other factors related to the procedure.
Thrombolysis in Myocardial Infarction (TIMI) Flow Six months Before / After 6 months
Pre dilatation - Balloon Type Six months 1. Non-compliant/ Semi compliant/ Compliant.
2. Balloon size -
3. Pressure -Occurrence of Cardiac death in the participants Six months The occurrence of death directly related to a cardiac event following the procedure. This outcome indicates a severe complication possibly stemming from factors such as acute myocardial infarction, arrhythmias, or other cardiovascular complications directly impacting the heart's function and leading to fatal consequences.
Lesion Length Six months \< 10 mm/ 10-20/ \> 20 mm
% of Stenosis Six months Before / After 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institute of CardioVascular Diseases
🇧🇩Dhaka, Bangladesh