Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
NCT ID: NCT06340373
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
303 participants
OBSERVATIONAL
2024-01-01
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )
NCT04104854
Drug-Coated Coronary Balloons in Different Clinical Scenarios
NCT06915597
Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty
NCT04482972
Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction
NCT06742125
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
NCT05750771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with native coronary lesions (2.0-3.5 mm diameter) after drug-coated balloon 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
DCB Angioplasty
Drug-coated balloons (DCB) are designed to deliver drugs (antiproliferative drugs: Paclitaxel, Sirolimus etc.) to the target lesion/vessel wall without leaving nothing behind unlike stent strut or drug delivery system. Drug coated balloons (DCB) allow the homogenous transfer of an anti-proliferative drug to reduce neo-intimal hyperplasia whilst maintaining normal vessel anatomy and function
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DCB Angioplasty
Drug-coated balloons (DCB) are designed to deliver drugs (antiproliferative drugs: Paclitaxel, Sirolimus etc.) to the target lesion/vessel wall without leaving nothing behind unlike stent strut or drug delivery system. Drug coated balloons (DCB) allow the homogenous transfer of an anti-proliferative drug to reduce neo-intimal hyperplasia whilst maintaining normal vessel anatomy and function
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Cardiovascular Diseases, Bangladesh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohsin Ahmed
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Mohsin Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiovascular Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of CardioVascular Diseases
Dhaka, , Bangladesh
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Brami P, Fischer Q, Pham V, Seret G, Varenne O, Picard F. Evolution of Coronary Stent Platforms: A Brief Overview of Currently Used Drug-Eluting Stents. J Clin Med. 2023 Oct 24;12(21):6711. doi: 10.3390/jcm12216711.
Bravo Baptista S. The third generation of drug-eluting stents: Reassuring data while we wait for the next one. Rev Port Cardiol (Engl Ed). 2021 Feb;40(2):77-80. doi: 10.1016/j.repc.2020.12.004. Epub 2020 Dec 25. No abstract available. English, Portuguese.
Jackson D, Tong D, Layland J. A review of the coronary applications of the drug coated balloon. Int J Cardiol. 2017 Jan 1;226:77-86. doi: 10.1016/j.ijcard.2016.09.045. Epub 2016 Sep 16.
Indermuehle A, Bahl R, Lansky AJ, Froehlich GM, Knapp G, Timmis A, Meier P. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart. 2013 Mar;99(5):327-33. doi: 10.1136/heartjnl-2012-302945. Epub 2013 Jan 18.
Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Bohm M, Cremers B. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012 Mar;5(3):323-30. doi: 10.1016/j.jcin.2012.01.008.
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
Ong PJ, Zeymer U, Waliszewski M, Tan J, Ho HH. Differences in clinical and angiographic profiles between Asian and Western patients with coronary artery disease: insights from the prospective "real world" paclitaxel-coated balloon registry. Int J Cardiol. 2014 Jul 15;175(1):199-200. doi: 10.1016/j.ijcard.2014.04.239. Epub 2014 Apr 28. No abstract available.
Akiyama T, Moussa I, Reimers B, Ferraro M, Kobayashi Y, Blengino S, Di Francesco L, Finci L, Di Mario C, Colombo A. Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. J Am Coll Cardiol. 1998 Nov 15;32(6):1610-8. doi: 10.1016/s0735-1097(98)00444-6.
Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
Pan L, Lu W, Han Z, Pan S, Wang X, Shan Y, Wang X, Zheng X, Li R, Zhou Y, Qin P, Shi Q, Zhou S, Zhang W, Guo S, Zhang P, Qin X, Sun G, Qin Z, Huang Z, Qiu C. Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study. Clin Res Cardiol. 2022 Jul;111(7):732-741. doi: 10.1007/s00392-021-01895-y. Epub 2021 Jul 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NICVD /Ethical/ 2023/ 32
Identifier Type: OTHER
Identifier Source: secondary_id
NICVD/ 2023/ 32
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.