Actively Recruiting
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Led by B. Braun Medical Industries Sdn. Bhd. · Updated on 2024-11-05
1436
Participants Needed
19
Research Sites
260 weeks
Total Duration
On this page
Sponsors
B
B. Braun Medical Industries Sdn. Bhd.
Lead Sponsor
B
B. Braun Melsungen AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.
CONDITIONS
Official Title
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older
- Able to understand the study and provide written informed consent
- Has clinical evidence of angina, abnormal functional study showing myocardial ischemia, or acute coronary syndrome (including unstable angina, NSTEMI, or STEMI at least 48 hours after primary PCI without thrombus in lesions to treat)
- Lesions suitable for treatment with drug-coated balloon or drug-eluting stent according to instructions
- Able to comply with study protocol and follow-up visits at 30 days, 6, 12, 24, and 36 months
- Presence of significant new large vessel coronary artery disease (reference vessel diameter �3.0 mm) with �30% diameter stenosis or intermediate stenosis with abnormal ischemic test or symptoms
- Successful lesion preparation with no flow-limiting dissection and residual stenosis �30% after balloon angioplasty
- Multivessel disease allowed if all criteria met
- Diffuse lesions included if proximal vessel diameter is at least 3.0 mm
You will not qualify if you...
- Allergy or intolerance to paclitaxel or Iopromide
- Severe allergy to contrast media
- Recent STEMI ongoing or less than 48 hours after primary PCI or thrombus in lesion
- Hemodynamically unstable NSTEMI
- Left ventricular ejection fraction less than 30%
- Unable to take dual antiplatelet or anticoagulant therapy for at least 6 months
- Non-cardiac conditions preventing study compliance
- Medical illnesses requiring cytostatic, radiation, or renal replacement therapy
- Participation in another clinical trial that could affect results
- Pregnancy or breastfeeding
- Under administrative or judicial custody
- Small vessel disease with vessel diameter less than 3.0 mm
- In-stent restenosis lesions
- Flow-limiting dissection or residual stenosis more than 30% after lesion preparation
- Untreatable lesions or coronary spasm without significant stenosis
- Left main or aorta-ostial lesions requiring revascularization
- Severely calcified or tortuous vessels preventing device use
- Prior coronary artery bypass graft surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, Malaysia, 88300
Actively Recruiting
2
Sarawak Heart Center
Kuching, Sarawak, Malaysia, 94300
Actively Recruiting
3
Sultan Idris Shah Serdang Hospital
Kajang, Selangor, Malaysia, 43000
Actively Recruiting
4
National Heart Institute Malaysia
Kuala Lumpur, Malaysia, 50400
Actively Recruiting
5
Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur, Malaysia, 50470
Actively Recruiting
6
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
7
Tan Tock Seng Hospital
Novena, Singapore, 308433
Actively Recruiting
8
National Heart Centre Singapore
Singapore, Singapore, 169609
Actively Recruiting
9
Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Actively Recruiting
10
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea, 24289
Actively Recruiting
11
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea, 15355
Actively Recruiting
12
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea, 10380
Actively Recruiting
13
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, South Korea, 51472
Actively Recruiting
14
Ulsan University Hospital
Donggu, Ulsan, South Korea, 44033
Actively Recruiting
15
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
16
Kangbuk Samsung Hospital
Seoul, South Korea, 13631
Actively Recruiting
17
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220216
Actively Recruiting
18
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
19
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Not Yet Recruiting
Research Team
H
Hooi Sian Eng, Ph.D
CONTACT
P
Philip Steen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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