KCT0006983
Recruiting
未知
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients with High Bleeding Risk
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Samsung Medical Center
- Enrollment
- 1350
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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