Coronary Artery DiseaseNCT06340373
Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
An observational study of Coronary Artery Disease, run by National Institute of Cardiovascular Diseases, Bangladesh at 1 site in Bangladesh.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DCB Angioplasty
- Type of treatment
- Medical device
- How many people
- 303 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
National Institute of CardioVascular Diseases
Dhaka, 1207
Sayeedur Rahman Khan, MD, +8801711850078, dr.rumibd@gmail.com
Md Zahid Hasan, MD, +8801723-218955, zhasan390@gmail.com
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- DCB Angioplasty
- Keywords
- Angioplasty, Balloon Angioplasty, Native Coronary Lesions, Coronary Artery Disease, Bangladesh
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB AngioplastyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: DCB Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months
Site of the lesion
Vessel \& Location
Measured: Six months
Lesion Length
< 10 mm/ 10-20/ > 20 mm
Measured: Six months
% of Stenosis
Before / After 6 months
Measured: Six months
Thrombolysis in Myocardial Infarction (TIMI) Flow
Before / After 6 months
Measured: Six months
Pre dilatation - Balloon Type
- Non-compliant/ Semi compliant/ Compliant.
- Balloon size -
- Pressure -
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsin Ahmed, National Institute of Cardiovascular Diseases, Bangladesh
- Investigators
- Prof. Mohsin Ahmed, MD, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340373
- Sponsor's protocol ID
- NICVD/ 2023/ 32
- Other IDs
- NICVD /Ethical/ 2023/ 32
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37959177Bravo 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.
PubMed 33358574Jackson 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.
PubMed 27792992Indermuehle 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.
PubMed 23335497Scheller 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.
PubMed 22440499Neumann 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.
PubMed 30165437Jeger 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.
PubMed 32473887Ong 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.
PubMed 24820752Akiyama 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.
PubMed 9822086Her 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.
PubMed 31565793Pan 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.
PubMed 34313800
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Angiographic Outcomes of Drug-coated Balloon Angioplasty After Successful Revascularization of Native Coronary Lesions
- ClinicalTrials.gov ID
- NCT06340373
- Acronym / sponsor ID
- NICVD/ 2023/ 32
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Balloon Angioplasty, Native Coronary Lesions, Coronary Artery Disease, Bangladesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, BangladeshUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with native coronary lesions (2.0-3.5 mm diameter) after drug-coated balloon angioplasty | – | Device: DCB AngioplastyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCB AngioplastyDrug-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 | Device | Patients with native coronary lesions (2.0-3.5 mm diameter) after drug-coated balloon angioplasty |
Primary outcome
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.
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.
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.
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.
Site of the lesion
Time frame: Six months
Vessel \& Location
Lesion Length
Time frame: Six months
< 10 mm/ 10-20/ > 20 mm
% of Stenosis
Time frame: Six months
Before / After 6 months
Thrombolysis in Myocardial Infarction (TIMI) Flow
Time frame: Six months
Before / After 6 months
Pre dilatation - Balloon Type
Time frame: Six months
1. Non-compliant/ Semi compliant/ Compliant. 2. Balloon size - 3. Pressure -
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 37959177Brami 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.
- Background: PubMed 33358574Bravo 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.
- Background: PubMed 27792992Jackson 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.
- Background: PubMed 23335497Indermuehle 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.
- Background: PubMed 22440499Scheller 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.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 32473887Jeger 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.
- Background: PubMed 24820752Ong 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.
- Background: PubMed 9822086Akiyama 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.
- Background: PubMed 31565793Her 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.
- Background: PubMed 34313800Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Mohsin Ahmed, MD principal investigator
National Institute of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by National Institute of Cardiovascular Diseases, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Mohsin Ahmed, MD (+8801613393186, profmohsinahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant (time frame: Six months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340373, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.