Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Chungbuk National University
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Gangneung Asan Hospital, University of Ulsan College of Medicine
RECRUITING
Gangneung
Chonnam National University Hospital
RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
Inha University Hospital
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Ewha Womans University College of Medicine
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Korea University Kuro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Boramae Medical Center
RECRUITING
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
RECRUITING
Seoul
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
RECRUITING
Uijeongbu-si
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Contact Information
Primary
Joo Myung Lee, MD, PhD
drone80@hanmail.net
82-2-3410-3391
Backup
Min-Jeong Seok
smg0492@naver.com
82-2-3410-3391
Time Frame
Start Date: 2022-07-29
Estimated Completion Date: 2028-12
Participants
Target number of participants: 1350
Treatments
Active_comparator: 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
Experimental: 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.
Sponsors
Collaborators: Seoul National University Bundang Hospital, Chonnam National University Hospital, Kangbuk Samsung Hospital, Sungkyunkwan University, Gyeongsang National University Hospital, Ewha Womans University, Korea University Guro Hospital, Seoul St. Mary's Hospital, Chungbuk National University, Keimyung University Dongsan Medical Center, Chung-Ang University Gwangmyeong Hospital, SMG-SNU Boramae Medical Center, Korea University Ansan Hospital, Inha University Hospital, Uijeongbu St. Mary Hospital, Wonju Severance Christian Hospital, Gangneung Asan Hospital, University of Ulsan College of Medicine
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov