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

NCT06340373 | Recruiting DMC

• 2 other identifiers: NICVD/ 2023/ 32NICVD /Ethical/ 2023/ 32
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Angioplasty; Balloon Angioplasty; Native Coronary Lesions; Coronary Artery Disease; Bangladesh

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• Site of the lesion

  Vessel \& Location

  Six months

• Lesion Length

  \< 10 mm/ 10-20/ \> 20 mm

  Six months

• % of Stenosis

  Before / After 6 months

  Six months

• Thrombolysis in Myocardial Infarction (TIMI) Flow

  Before / After 6 months

  Six months

• Pre dilatation - Balloon Type

  1. Non-compliant/ Semi compliant/ Compliant. 2. Balloon size - 3. Pressure -

  Six months

Study Arms (1)

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

Device: DCB Angioplasty

Interventions

DCB Angioplasty DEVICE

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

Patients with native coronary lesions (2.0-3.5 mm diameter) after drug-coated balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Bangladesh: lead

Study Sites (1)

National Institute of CardioVascular Diseases

Dhaka, 1207, Bangladesh

RECRUITING

Related Publications (11)

• 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.

  PMID: 37959177 BACKGROUND

• 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.

  PMID: 33358574 BACKGROUND

• 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.

  PMID: 27792992 BACKGROUND

• 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.

  PMID: 23335497 BACKGROUND

• 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.

  PMID: 22440499 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

• 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.

  PMID: 32473887 BACKGROUND

• 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.

  PMID: 24820752 BACKGROUND

• 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.

  PMID: 9822086 BACKGROUND

• 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.

  PMID: 31565793 BACKGROUND

• 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.

  PMID: 34313800 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Prof. Mohsin Ahmed, MD

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Mohsin Ahmed, MD

CONTACT

+8801613393186; profmohsinahmed@gmail.com

Dr. SA Shiblee, MPH

CONTACT

+8801834610028; shibleemusic@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

BA (1)