Drug-Coated Balloon in Patients With High Bleeding Risk

NCT05221931 | Active Not Recruiting DMC

• 1 other identifier: DCBHBR2021-12-111-001
• Study Type: interventional
• Target: 1,359
• Locations: 1 country
• Sites: 17

Brief Summary

DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. 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).

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; De-Novo Coronary Lesion; Drug-Coated Balloon; High Bleeding Risk; Prognosis

Outcome Measures

Primary Outcomes (1)

• Target vessel failure (TVF)

  a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)

  2 years from last patient enrollment

Secondary Outcomes (39)

• BARC type 2, 3 or 5 bleeding (Major secondary endpoint)

  2 years from last patient enrollment

• Cardiovascular death

  2 years from last patient enrollment

• All-cause death

  2 years from last patient enrollment

• Target-vessel MI

  2 years from last patient enrollment

• Non-target vessel related MI

  2 years from last patient enrollment

Study Arms (2)

DES group

ACTIVE COMPARATOR

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

Procedure: Percutaneous coronary intervention

DCB group

EXPERIMENTAL

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.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

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; DES group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 19 years of age
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
• 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
• 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

You may not qualify if:

• Patients unable to provide consent
• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
• 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
• Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year
• Patients who may result in protocol non-compliance (site investigator's medical judgment)
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
• Patients with severe valvular heart disease requiring open heart surgery
• Pregnant or lactating women

Sponsors & Collaborators

• Samsung Medical Center: lead
• Kangbuk Samsung Hospital, Sungkyunkwan University: collaborator
• Ewha Womans University: collaborator
• Korea University Guro Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Korea University Ansan Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Chung-Ang University Gwangmyeong Hospital: collaborator
• Gangneung Asan Hospital, University of Ulsan College of Medicine: collaborator
• Gyeongsang National University Hospital: collaborator
• Uijeongbu St. Mary Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Inha University Hospital: collaborator
• Chungbuk National University: collaborator
• Wonju Severance Christian Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (17)

Korea University Ansan Hospital

Ansan, South Korea

Location

Chungbuk National University

Cheongju-si, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Gangneung Asan Hospital, University of Ulsan College of Medicine

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Ewha Womans University College of Medicine

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Kuro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joo Myung Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, multi-center, open-label, randomized controlled, noninferiority trial

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 3, 2022
• Study Start: July 29, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

KR (17)