Comparing drug-coated balloons and drug-eluting stents for treating large coronary artery disease
Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
This study is testing whether a new type of balloon treatment is just as safe and effective as a standard stent for people with large coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1436 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | B. Braun Medical Industries Sdn. Bhd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 19 sites (Kota Kinabalu, Sabah and 18 other locations) |
| Trial ID | NCT05846893 on ClinicalTrials.gov |
What this trial studies
This international multicenter trial evaluates the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease. It aims to demonstrate that DCB is non-inferior to DES for clinical outcomes in patients with de novo lesions. Participants will be randomly assigned to receive either DCB or DES, and their clinical outcomes will be monitored over a period of 36 months. The study addresses a gap in randomized controlled trial data regarding DCB use in larger coronary artery lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinical evidence of angina or myocardial ischemia due to target lesions.
Not a fit: Patients with lesions not suitable for percutaneous coronary intervention (PCI) or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with large coronary artery disease.
How similar studies have performed: Previous studies have suggested the safety of DCB for larger coronary lesions, but this trial is among the first to rigorously compare it with current-generation DES in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patient-related:
1. Patient must be ≥ 18 years of age
2. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\]
4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
5. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
* Lesion-related:
1. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with abnormal functional test or symptom of ischemia
2. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
* Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.
* In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.
Exclusion Criteria:
* Patient-related:
1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
2. Severe allergy to contrast media
3. Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
4. NSTEMI hemodynamically unstable
5. Known left ventricular ejection fraction of \<30%
6. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
7. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
8. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
9. Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry
10. Pregnancy or lactation
11. Patient under administrative or judicial custody
* Lesion-related:
1. Small vessel disease, defined as \<3.0 mm of reference vessel diameter by visual estimation
2. In-stent restenosis lesions for study lesions
3. Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:
(i) Flow limiting dissection with TIMI flow \< III (ii) Residual diameter stenosis \>30%
\* The case of persistent ischemic symptoms/signs is up to the operator's decision
4. Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis
5. Left main disease or aorta-ostial lesion requiring revascularization
6. Severely calcified or tortuous vessels precluding DCB or DES application
7. Prior Coronary Artery Bypass Graft (CABG)
Where this trial is running
Kota Kinabalu, Sabah and 18 other locations
- Queen Elizabeth II Hospital — Kota Kinabalu, Sabah, Malaysia (Recruiting)
- Sarawak Heart Center — Kuching, Sarawak, Malaysia (Recruiting)
- Sultan Idris Shah Serdang Hospital — Kajang, Selangor, Malaysia (Recruiting)
- National Heart Institute Malaysia — Kuala Lumpur, Malaysia (Recruiting)
- Cardiac Vascular Sentral Kuala Lumpur — Kuala Lumpur, Malaysia (Recruiting)
- University Malaya Medical Centre — Kuala Lumpur, Malaysia (Recruiting)
- Tan Tock Seng Hospital — Novena, Singapore (Recruiting)
- National Heart Centre Singapore — Singapore, Singapore (Recruiting)
- Khoo Teck Puat Hospital — Singapore, Singapore (Recruiting)
- Kangwon National University Hospital — Chuncheon, Gangwon-do, South Korea (Recruiting)
- Korea University Ansan Hospital — Ansan-si, Gyeonggi-do, South Korea (Recruiting)
- Inje University Ilsan Paik Hospital — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
- Gyeongsang National University Changwon Hospital — Changwon, Gyeongsangnam-do, South Korea (Recruiting)
- Ulsan University Hospital — Donggu, Ulsan, South Korea (Recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
- Far Eastern Memorial Hospital — New Taipei City, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Not_yet_recruiting)
Study contacts
- Study coordinator: Hooi Sian Eng, Ph.D
- Email: hooi.eng@bbraun.com
- Phone: +60-12-428-2880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.