Drug-Coated Balloon in Patients With High Bleeding Risk
NCT ID: NCT05221931
Last Updated: 2025-12-19
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
1350 participants
INTERVENTIONAL
2022-07-29
2028-12-31
Brief Summary
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The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
Detailed Description
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As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCT demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels with reference vessel size\<3.0mm. However, studies exploring the feasibility of DCB in de-novo coronary artery stenosis beyond small vessels are limited. Furthermore, there is scarce data comparing DCB with DES in patients with de-novo coronary artery stenosis and high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In previous BASKET-SMALL 2 trial, DCB showed noninferiority to DES in patients with de-novo coronary artery stenosis and small vessel disease. However, this trial was conducted in non-HBR patients, and the number of participated patients was insufficient. In another RCT, DEBUT trial exclusively enrolled patients with HBR and de-novo coronary artery stenosis. Although the DEBUT trial showed superiority of DCB angioplasty over implantation of BMS to treat de-novo coronary artery stenosis in patients with HBR, the results could not be applicable in contemporary practice because BMS has been no longer in clinical use. Recently, multiple RCTs have proved short-term DAPT (1-3 months) has comparable efficacy to longer term DAPT in HBR patients using latest second-generation DES.
On this background, the current trial aims to compare clinical outcomes between DCB and DES to treat de-novo coronary artery stenosis in patients with HBR receiving guideline-directed short-term DAPT.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DES group
Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure
Percutaneous coronary intervention
1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent \[Boston Scientific, USA\], Prevail \[Medtronic, USA\], or SeQuent Please, SeQuent Please NEO \[B-Braun, Germany\])
DCB group
Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography.
In DCB group, Agent (Boston Scientific, USA), Prevail (Medtronic, USA), or SeQuent Please, SeQuent Please NEO (B-Braun, Germany) will be used during the index procedure.
Percutaneous coronary intervention
1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent \[Boston Scientific, USA\], Prevail \[Medtronic, USA\], or SeQuent Please, SeQuent Please NEO \[B-Braun, Germany\])
Interventions
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Percutaneous coronary intervention
1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent \[Boston Scientific, USA\], Prevail \[Medtronic, USA\], or SeQuent Please, SeQuent Please NEO \[B-Braun, Germany\])
Eligibility Criteria
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Inclusion Criteria
2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
4. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated \< 3 years (8) Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis (11) Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons
Exclusion Criteria
2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
4. Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year
5. Patients who may result in protocol non-compliance (site investigator's medical judgment)
6. Patients with cardiogenic shock or cardiac arrest
7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
8. Patients with severe valvular heart disease requiring open heart surgery
9. Pregnant or lactating women
19 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Korea University Ansan Hospital
OTHER
Chonnam National University Hospital
OTHER
Chung-Ang University Gwangmyeong Hospital
OTHER
Gangneung Asan Hospital, University of Ulsan College of Medicine
UNKNOWN
Gyeongsang National University Hospital
OTHER
Uijeongbu St. Mary Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Inha University Hospital
OTHER
Chungbuk National University
OTHER
Wonju Severance Christian Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Kangbuk Samsung Hospital, Sungkyunkwan University
OTHER
Ewha Womans University
OTHER
Korea University Guro Hospital
OTHER
Samsung Medical Center
OTHER
Responsible Party
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Joo Myung Lee
Professor
Principal Investigators
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Joo Myung Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Chungbuk National University
Cheongju-si, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
Inha University Hospital
Incheon, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Ewha Womans University College of Medicine
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Kuro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sunwon Kim, MD, PhD
Role: primary
Jang-Whan Bae, MD, PhD
Role: primary
Hyuck-Jun Yoon, MD, PhD
Role: primary
Hanbit Park, MD, PhD
Role: primary
Young Joon Hong, MD, PhD
Role: primary
Seung Hun Lee, MD, PhD
Role: backup
Sang Yeub Lee, MD, PhD
Role: primary
Sang Don Park, MD, PhD
Role: primary
Hangyul Kim, MD, PhD
Role: primary
Jin-Sin Koh, MD, PhD
Role: backup
Ki-Hyun Jeon, MD, PhD
Role: primary
So-Dam Jung, MD
Role: primary
Jong-Young Lee, MD, PhD
Role: primary
Woochan Kwon, MD
Role: backup
Dong-Oh Kang, MD
Role: primary
Joo Myung Lee, MD, MPH, PhD
Role: primary
David Hong, MD
Role: backup
Hyun Sung Joh, MD
Role: primary
Eun Ho Choo, MD, PhD
Role: primary
Kwan Yong Lee, MD, PhD
Role: backup
Seonghyeon Bu, MD, PhD
Role: primary
Chan Joon Kim, MD, PhD
Role: backup
Sung Gyun Ahn, MD, PhD
Role: primary
Other Identifiers
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DCBHBR2021-12-111-001
Identifier Type: -
Identifier Source: org_study_id