Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
NCT ID: NCT05846893
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1436 participants
INTERVENTIONAL
2023-09-07
2028-09-30
Brief Summary
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Detailed Description
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Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation).
The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SeQuent® Please NEO drug-coated balloon catheter
SeQuent® Please NEO drug-coated balloon catheter
Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries
Current-generation drug-eluting stent
Current-generation drug-eluting stent
Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries
Interventions
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SeQuent® Please NEO drug-coated balloon catheter
Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries
Current-generation drug-eluting stent
Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries
Eligibility Criteria
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Inclusion Criteria
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
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
(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)
18 Years
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
Ulsan University Hospital
OTHER
European Cardiovascular Research Center
NETWORK
Seoul National University Hospital
OTHER
Universität des Saarlandes
OTHER
B. Braun Medical Industries Sdn. Bhd.
INDUSTRY
Responsible Party
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Principal Investigators
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Eun-Seok Shin, MD, Ph.D
Role: STUDY_CHAIR
Ulsan University Hospital
Locations
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Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, Malaysia
Sarawak Heart Center
Kuching, Sarawak, Malaysia
Sultan Idris Shah Serdang Hospital
Kajang, Selangor, Malaysia
National Heart Institute Malaysia
Kuala Lumpur, , Malaysia
Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Tan Tock Seng Hospital
Novena, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Khoo Teck Puat Hospital
Singapore, , Singapore
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, South Korea
Ulsan University Hospital
Donggu, Ulsan, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Houng Bang Liew, MD
Role: primary
Tiong Kiam Ong, MD
Role: primary
Kamaraj Selvaraj, MD
Role: primary
Shaiful Azmi Yahaya, MD
Role: primary
Rosli Mohd Ali, MD
Role: primary
Ahmad Syadi Mahmood Zuhdi, MD
Role: primary
Hee Hwa Ho, MD
Role: primary
Chee Tang Chin, MD
Role: primary
Patrick Zhan Yun Lim, MD
Role: primary
Ae-Young Her, MD, Ph.D
Role: primary
Sunwon Kim, MD, Ph.D
Role: primary
Joon-Hyung Doh, MD, Ph.D
Role: primary
Jong Hwa Ahn, MD, Ph.D
Role: primary
Chang-Wook Nam, MD, Ph.D
Role: primary
Jong-Young Lee, MD, Ph.D
Role: primary
Jung-Cheng Hsu, MD
Role: primary
Wen-Lieng Lee, MD
Role: primary
I-Chang Hsieh, MD, Ph.D
Role: primary
Other Identifiers
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AAG-G-H-2124
Identifier Type: -
Identifier Source: org_study_id
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