Observing outcomes of drug-coated balloon angioplasty in coronary artery disease
Clinical & Angiographic Outcomes of Drug-coated Balloon Angioplasty After Successful Revascularization of Native Coronary Lesions
This study is testing how well drug-coated balloon angioplasty works for people with coronary artery disease after they've had successful heart surgery, specifically looking at their heart health and symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 303 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06340373 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical and angiographic outcomes of drug-coated balloon (DCB) angioplasty in patients with native coronary lesions who have undergone successful revascularization. The study will assess various angiographic results, including percentage diameter stenosis and restenosis, as well as clinical outcomes such as worsening angina and cardiac mortality. Conducted at the National Institute of Cardiovascular Diseases in Bangladesh, the study focuses on the unique context of the Bangladeshi population, where no similar research has been previously conducted.
Who should consider this trial
Good fit: Ideal candidates are patients who have successfully undergone DCB angioplasty for native coronary lesions with a diameter between 2.0 mm and 3.5 mm at least six months prior.
Not a fit: Patients with severe renal impairment, low ejection fraction, or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of DCB angioplasty, potentially improving treatment strategies for coronary artery disease.
How similar studies have performed: While DCB therapy has been widely accepted in clinical practice for in-stent restenosis, this specific observational study is novel as it focuses on the Bangladeshi population and the outcomes of DCB in de novo coronary artery disease.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- National Institute of CardioVascular Diseases — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Prof. Mohsin Ahmed, MD — National Institute of Cardiovascular Diseases
- Study coordinator: Prof. Mohsin Ahmed, MD
- Email: profmohsinahmed@gmail.com
- Phone: +8801613393186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.