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

April 2, 2024 updated by: Mohsin Ahmed, National Institute of Cardiovascular Diseases, Bangladesh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1207
        • Recruiting
        • National Institute of Cardiovascular Diseases
        • Contact:
        • Contact:
        • Principal Investigator:
          • Prof. Mohsin Ahmed, MD
        • Sub-Investigator:
          • Dr. Sayeedur Rahman Khan, MD
        • Sub-Investigator:
          • Dr. Md Zahid Hasan, MD
        • Sub-Investigator:
          • Dr. Shariful Islam, MD
        • Sub-Investigator:
          • Dr. CM Kudrat E Khuda, MD
        • Sub-Investigator:
          • Dr. Mohammad Arifur Rahman, MD
        • Sub-Investigator:
          • Dr. Md Matiur Rahman, MD
        • Sub-Investigator:
          • Dr. SA Shiblee, MPH
        • Sub-Investigator:
          • Md. Habibur Rahman, M.Sc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Site of the lesion
Time Frame: Six months
Vessel & Location
Six months
Lesion Length
Time Frame: Six months
< 10 mm/ 10-20/ > 20 mm
Six months
% of Stenosis
Time Frame: Six months
Before / After 6 months
Six months
Pre dilatation - Balloon Type
Time Frame: Six months
  1. Non-compliant/ Semi compliant/ Compliant.
  2. Balloon size -
  3. Pressure -
Six months
CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Thrombolysis in Myocardial Infarction (TIMI) Flow
Time Frame: Six months
Before / After 6 months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Bangladesh

Investigators

  • Principal Investigator: Prof. Mohsin Ahmed, MD, National Institute of Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICVD/ 2023/ 32
  • NICVD /Ethical/ 2023/ 32 (Other Identifier: National Institute of Cardiovascular Diseases(NICVD))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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