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Drug-Coated Balloon in Patients With High Bleeding Risk (DCB-HBR)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, De-Novo Coronary Lesion, Drug-Coated Balloon, High Bleeding Risk, Prognosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must be at least 19 years of age
  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 bleed (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:

  1. Patients unable to provide consent
  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 <1 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

Sites / Locations

  • Korea University Ansan HospitalRecruiting
  • Chungbuk National UniversityRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Gangneung Asan Hospital, University of Ulsan College of MedicineRecruiting
  • Chonnam National University HospitalRecruiting
  • Chung-Ang University Gwangmyeong HospitalRecruiting
  • Inha University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
  • The Catholic University of Korea, Uijeongbu St. Mary's HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DES group

DCB group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiovascular death
Cardiovascular death
All-cause death
All-cause death
Target-vessel MI
Target-vessel MI
Non-fatal MI
Non-fatal MI
Clinically indicated target-lesion revascularization (TLR)
Clinically indicated target-lesion revascularization (TLR)
Clinically indicated TVR
Clinically indicated TVR
Any revascularization
Any revascularization
Vessel or stent thrombosis
definite or probable by Academic Research Consortium (ARC) definition
Cardiovascular death or target-vessel MI
Cardiovascular death or target-vessel MI
All-cause death or non-fatal MI
All-cause death or non-fatal MI
Target lesion failure (TLF)
a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
All-cause death, non-fatal MI, or TVR
All-cause death, non-fatal MI, or TVR
Major bleeding (Major secondary endpoint)
BARC type 2, 3 or 5 bleeding
Major bleeding
The Thrombolysis in Myocardial Infarction (TIMI) major bleeding

Full Information

First Posted
January 23, 2022
Last Updated
October 16, 2023
Sponsor
Samsung Medical Center
Collaborators
Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Korea University Ansan Hospital, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gyeongsang National University Hospital, Uijeongbu St. Mary Hospital, Keimyung University Dongsan Medical Center, Inha University Hospital, Chungbuk National University, Wonju Severance Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05221931
Brief Title
Drug-Coated Balloon in Patients With High Bleeding Risk
Acronym
DCB-HBR
Official Title
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Korea University Ansan Hospital, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gyeongsang National University Hospital, Uijeongbu St. Mary Hospital, Keimyung University Dongsan Medical Center, Inha University Hospital, Chungbuk National University, Wonju Severance Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 under intravascular imaging-guided optimization in patients with high bleeding risk (HBR).
Detailed Description
Second-generation drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompanies disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which leads to both increased ischemic and bleeding events. 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 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 RCTs demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels. However, studies exploring the feasibility of DCB in de-novo coronary lesions are limited. In particular, there are scarce data comparing DCB with DES in patients with high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In the previous two RCTs, DCB showed noninferiority to DES in lesions in large vessels. Nevertheless, these studies were conducted in non-HBR patients and the number of participated patients was insufficient. In another RCT, only patients with HBR were included, but the efficacy of DCB was compared with BMS not DES. Recently, studies have proved short term (1-3 months) DAPT has comparable efficacy to longer DAPT in HBR patients using latest second-generation DES. On this background, this trial aims to compare clinical outcomes between DCB and DES in de-novo coronary lesions in large vessels in patients with HBR receiving short term DAPT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, De-Novo Coronary Lesion, Drug-Coated Balloon, High Bleeding Risk, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multi-center, open-label, randomized controlled, noninferiority trial
Masking
Outcomes Assessor
Masking Description
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DES group
Arm Type
Active Comparator
Arm Description
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
Arm Title
DCB group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
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])
Primary Outcome Measure Information:
Title
Target vessel failure (TVF)
Description
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)
Time Frame
2 years from last patient enrollment
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
Cardiovascular death
Time Frame
2 years from last patient enrollment
Title
All-cause death
Description
All-cause death
Time Frame
2 years from last patient enrollment
Title
Target-vessel MI
Description
Target-vessel MI
Time Frame
2 years from last patient enrollment
Title
Non-fatal MI
Description
Non-fatal MI
Time Frame
2 years from last patient enrollment
Title
Clinically indicated target-lesion revascularization (TLR)
Description
Clinically indicated target-lesion revascularization (TLR)
Time Frame
2 years from last patient enrollment
Title
Clinically indicated TVR
Description
Clinically indicated TVR
Time Frame
2 years from last patient enrollment
Title
Any revascularization
Description
Any revascularization
Time Frame
2 years from last patient enrollment
Title
Vessel or stent thrombosis
Description
definite or probable by Academic Research Consortium (ARC) definition
Time Frame
2 years from last patient enrollment
Title
Cardiovascular death or target-vessel MI
Description
Cardiovascular death or target-vessel MI
Time Frame
2 years from last patient enrollment
Title
All-cause death or non-fatal MI
Description
All-cause death or non-fatal MI
Time Frame
2 years from last patient enrollment
Title
Target lesion failure (TLF)
Description
a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR
Time Frame
2 years from last patient enrollment
Title
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Description
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Time Frame
2 years from last patient enrollment
Title
All-cause death, non-fatal MI, or TVR
Description
All-cause death, non-fatal MI, or TVR
Time Frame
2 years from last patient enrollment
Title
Major bleeding (Major secondary endpoint)
Description
BARC type 2, 3 or 5 bleeding
Time Frame
2 years from last patient enrollment
Title
Major bleeding
Description
The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Time Frame
2 years from last patient enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 bleed (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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Myung Lee, MD, PhD
Phone
82-2-3410-3391
Email
drone80@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Jeong Seok
Phone
82-2-3410-3391
Email
smg0492@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunwon Kim, MD, PhD
Email
sunwon11@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sunwon Kim, MD, PhD
Facility Name
Chungbuk National University
City
Cheongju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang-Whan Bae, MD, PhD
Email
drcorazon@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jang-Whan Bae, MD, PhD
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuck-Jun Yoon, MD, PhD
Email
hippsons@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyuck-Jun Yoon, MD, PhD
Facility Name
Gangneung Asan Hospital, University of Ulsan College of Medicine
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanbit Park, MD, PhD
Email
phb8012@gmail.com
First Name & Middle Initial & Last Name & Degree
Hanbit Park, MD, PhD
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Joon Hong, MD, PhD
Email
hyj200@hanmail.net
First Name & Middle Initial & Last Name & Degree
Seung Hun Lee, MD, PhD
Email
lsh8602@naver.com
First Name & Middle Initial & Last Name & Degree
Young Joon Hong, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seung Hun Lee, MD, PhD
Facility Name
Chung-Ang University Gwangmyeong Hospital
City
Gwangmyeong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeub Lee, MD, PhD
Email
louisahj@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang Yeub Lee, MD, PhD
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Don Park, MD, PhD
Email
denki1@inha.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang Don Park, MD, PhD
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hangyul Kim, MD, PhD
Email
13medicine@naver.com
First Name & Middle Initial & Last Name & Degree
Jin-Sin Koh, MD, PhD
Email
kjs0175@gmail.com
First Name & Middle Initial & Last Name & Degree
Hangyul Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jin-Sin Koh, MD, PhD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-Hyun Jeon, MD, PhD
Email
imcardio@gmail.com
First Name & Middle Initial & Last Name & Degree
Ki-Hyun Jeon, MD, PhD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
Phone
82-2-3410-2575
Email
drone80@hanmal.net
First Name & Middle Initial & Last Name & Degree
David Hong, MD
Phone
82-2-3410-2575
Email
hongdawi@naver.com
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Ki Hong Choi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Taek Kyu Park, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeong Hoon Yang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Young Bin Song, MD, PhD
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD, PhD
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Ho Choo, MD, PhD
Email
cmcchu@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Kwan Yong Lee, MD, PhD
Email
kyle210@naver.com
First Name & Middle Initial & Last Name & Degree
Eun Ho Choo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kwan Yong Lee, MD, PhD
Facility Name
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Uijeongbu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seonghyeon Bu, MD, PhD
Email
buseonghyeon@gmail.com
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, MD, PhD
Email
godandsci@naver.com
First Name & Middle Initial & Last Name & Degree
Seonghyeon Bu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, MD, PhD
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Gyun Ahn, MD, PhD
Email
sgahn@yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Sung Gyun Ahn, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Time Frame
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Access Criteria
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Learn more about this trial

Drug-Coated Balloon in Patients With High Bleeding Risk

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