Clinical trial NCT06340373: Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
Official title: Clinical & Angiographic Outcomes of Drug-coated Balloon Angioplasty After Successful Revascularization of Native Coronary Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Angioplasty
Balloon Angioplasty
Native Coronary Lesions
Coronary Artery Disease
Bangladesh
Lead sponsor: National Institute of Cardiovascular Diseases, Bangladesh
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant
timeFrame: Six months
measure: Number of participants with target vessel Myocardial infarction
timeFrame: Six months
measure: Ischemia-driven Target lesion revascularization (TLR) each participant
timeFrame: Six months
measure: Occurrence of Cardiac death in the participants
timeFrame: Six months
measure: Site of the lesion
timeFrame: Six months
measure: Lesion Length
timeFrame: Six months
measure: % of Stenosis
timeFrame: Six months
measure: Thrombolysis in Myocardial Infarction (TIMI) Flow
timeFrame: Six months
measure: Pre dilatation - Balloon Type
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Institute of CardioVascular Diseases
Study officials:
affiliation: National Institute of Cardiovascular Diseases
name: Prof. Mohsin Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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