Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions

Coronary Artery Disease Clinical Trial

Official title:

Clinical & Angiographic Outcomes of Drug-coated Balloon Angioplasty After Successful Revascularization of Native Coronary Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340373
• Other study ID #: NICVD/ 2023/ 32
• Secondary ID: NICVD /Ethical/
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: National Institute of Cardiovascular Diseases, Bangladesh
• Contact: Prof. Mohsin Ahmed, MD
• Phone: +8801613393186
• Email: profmohsinahmed[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 303
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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

Locations

Country	Name	City	State
Bangladesh	National Institute of CardioVascular Diseases	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant	Exacerbation of chest pain symptoms following the procedure, possibly indicating complications or inadequate treatment effectiveness.	Six months
Primary	Number of participants with target vessel Myocardial infarction	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.	Six months
Primary	Ischemia-driven Target lesion revascularization (TLR) each participant	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.	Six months
Primary	Occurrence of Cardiac death in the participants	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.	Six months
Primary	Site of the lesion	Vessel & Location	Six months
Primary	Lesion Length	< 10 mm/ 10-20/ > 20 mm	Six months
Primary	% of Stenosis	Before / After 6 months	Six months
Primary	Thrombolysis in Myocardial Infarction (TIMI) Flow	Before / After 6 months	Six months
Primary	Pre dilatation - Balloon Type	Non-compliant/ Semi compliant/ Compliant.; Balloon size -; Pressure -	Six months